Enfamil 2022 Formula Recall and Adulteration Issues: What You Need to Know - Maternity Community (2023)

overview

familyis one of the most popular formula brands, but are there any recalls for this brand? Is it safe and healthy for your baby? What products were included in the Enfamil formula recalls and what should you do if you purchased these items?

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find thebest formulaIt can be quite a challenge for your baby. In addition to checking the ingredients and nutritional values ​​of these infant formula products, you should also be on the lookout for product recalls.

If you are looking for onenew formulafor your baby you will find many that have a similar composition to breast milk.

You can feel safe choosing your baby's formula from well-known brands like Enfamil.

Find alternatives to withdrawn infant formula

the massiveSimilac CollectionEarlier this year, this, along with other issues plaguing suppliers (such as logistics issues amid the pandemic), led to a U.S. formula crisis.

To this day, many parents struggle to find baby food because most store shelves are empty or their favorite brands are unavailable.

Babies without metabolic issues and those who don't need special formula can try the following US brands with doctor approval:

• Bobbie Organic Infant Formula
• ByHeart Baby Formula
• Infant Formula Serenity Kids A2(Use our codeMHCfor 15% discount on early orders!)

*Check out our interviews with the founders of Serenity Kids in theirsBaby food, and yourbags for baby food.

We also recommend the followingEuropean formulasIf you're looking for the best organic baby food options:

• Hipp Dutch Combiotic Formula
• Holle Bio (Bio)
• it is worth living
• Kendamil
• Loulouka

However, be sure to consult your pediatrician before changing your baby's formula, even for shortages. Many European formulas do not have FDA approval. Still, many parents prefer them to American brands.

Does Enfamil have a recall?

Drinking or ingesting contaminated products can lead to gastrointestinal problems, other health problems, or even death in severe cases.

That is why it is always important to pay attention to itformula memoriesand notices or news about security issues.

The following are formula recalls and adulteration issues for Enfamil:

Enfamil Powder Formula Manipulation (2019)

One of the recent issues with Enfamil did not result in a formula recall. However, many parents raised concerns that this may have affected several of the brand's products.

Ashley Frydrych purchased two bottles of Enfamil baby formula at a Publix supermarket in Tampa Bay, Florida on June 1, 2019. While the first bottle was fine, she noticed that the second bottle was weird. (1)(2)

At first she thought the contents of the second container didn't smell or look like the regular formula she buys for her baby because the brand had changed their formulation. (1)

She prepared a bottle, but her baby refused to drink it. (1)

„I tried to feed him at 11 and he wouldn't take the bottle. I thought it was full. I tried to feed him again at 3am. He didn't take the bottle, I thought maybe his stomach hurtexplained Frydrych. (1)

The next morning she continued to use the formula, but her husband noticed that the contents separated immediately. The powdered contents settled to the bottom while the water was on top. (1)(2)

When they checked the container, they were surprised to find that the contents smelled and looked more like flour than baby food. (1)

Her husband tasted the contents and confirmed it was flour, Frydrych told news channel WFTS. (1)(2)

„I was initially very upset with myself for realizing I was different, but we dismissed it. I didn't trust my instincts and neither did my husband at first. The formula was in the container without the pouch.

It's an infant formula. It's her lifeline, so why would you mess with it? The real concern for me, what if it was worse? What if it was a purifier? What if it was an allergic reaction?”

Concerned that other formulas had also been tampered with, Frydrych immediately reported this to Publix. The store quickly became active.

The supermarket released the following statement: (1)

„Food safety is our top priority. The incident was reported to the FDA for investigation. We checked the other lot and date codes for the remaining product and they were all formulas.”

Frydrych also called Enfamil and asked the company to change its packaging to avoid similar incidents in the future. (1)

In response, Enfamil assured its customers that they were confident in the safety of its products and its long tradition of quality.

Enfamil released the following statement: (1)

„We encourage consumer feedback which we can share with our team who are constantly looking for ways to innovate our products and packaging.

Importantly, we let parents know that we take potential manipulation issues very seriously.

We manufacture all our packaging to be tamper evident and tamper evident and draw retail customers attention to the liberal terms of our return policy, which aims to ensure that products returned to a retailer are not returned to the shelf or otherwise made available. for sale.

We encourage consumers to check the appearance of the packaging, label and product - even slight differences can be significant.

If a consumer is uncomfortable using a product they have purchased, they can call us at 1-800-BABY123.“

After conducting separate investigations, Publix and Enfamil assured clients that this was being considered an isolated case. As such, no recalls were issued for the formula. (1)(2)

CVS recall of enfamil formulas (2018)

In 2018, CVS temporarily pulled all Enfamil formulas from stores across the country after a mother, Alison Denning, purchased an adulterated container at a CVS store in Oldsmar, Fla. (1)(3)

According to Denning, the protective seal on the lid appeared to be intact, but she was surprised when the inner seal was broken. Instead of formula, the contents smelled of wheat flour. (1)(3)

Just to be sure, she bought another formula to compare the contents of the first. (4)

She explained that the contents of the second formula were slightly yellowish in color, more difficult to package, and looked a bit grainier than the first one she received. This confirmed his suspicion that the first pack did not contain the formula. (1)

So she reported the problem to CVS. The store offered to refund her purchase, but Denning also informed Enfamil about the security issue.

Enfamil's maker, Mead Johnson, sent her a shipping box so they could test the product.

Even before Mead Johnson tested the potentially adulterated formula, CVS Pharmacy issued a temporary recall of all Enfamil and pulled the rest of its inventory off shelves. (3)

CVS announced: (3)

„The health and safety of our customers is our top priority and we have robust quality assurance policies and procedures in place to ensure the quality and safety of the products we sell.

We take seriously our customers' reports of suspected counterfeiting of Enfamil purchased from our Oldsmar store. We will be in touch with the supplier and as a precaution have removed all Enfamil products from this store pending the outcome of our investigation.”

After completing their investigation, CVS and Mead Johnson said it was an isolated case. (3)

No official Enfamil recall has been issued. However, the company encourages anyone who purchases one of its products to check the appearance of the packaging, as even seemingly minor differences can hide a security issue or tampering. (5)

Enfamil assures its customers that its products are safe, but it takes calls to its hotline (1-800-BABY123) from anyone who believes its formula has been tampered with. (5)

Possible adulteration of the product Enfamil AR (2018)

Buckeye, Arizona, resident Chelsea Bellinger believes the Enfamil AR formula she purchased from a nearby Arizona Walmart may have been tampered with. (4)

According to Bellinger, her husband prepared several bottles of baby formula and put them in the refrigerator before bed.

The next morning she noticed that the contents of the powder had settled in all the vials that her husband had prepared. The liquid and solid parts have been completely separated. (4)

At first she thought her husband just didn't shake the bottles properly while preparing them. But she was surprised when the powdery contents still didn't dissolve when she shook the bottles. (4)

So she decided to reheat the bottles but noticed the consistency didn't look good. Upon checking, she saw that the bottles had lumpy solids at the bottom. She threw everything in the sink. (4)

She also checked the powder in the container. The consistency and color were different than what she was used to seeing. But she wasn't sure what powder could be used to replace the formula. (4)

Bellinger reported the issue to Walmart. (4)

A company spokesman said it reviewed store security footage and conducted an internal review to see if there had been any possible tampering. (6)

It was declared as an isolated case. Neither Walmart nor Enfamil have issued a recall of relevant products related to Bellinger's concerns. (4)

In response to the incident, Enfamil encouraged its customers to check the packaging of any infant formula or baby products they purchased for signs of tampering. You are encouraged to call the Company's hotline at 1-800-BABY123 with any questions. (4)

Enfamil neonatal store recall (2011)

Enfamil Newborn stock was recalled from Supervalu, Walgreen Co, Kroger, and Walmart stores in 2011 due to reports that it could cause a rare bacterial infection. (7)

Avery Cornett, a 10-day-old Missouri child, reportedly died after drinking Enfamil Premium Newborn, batch number ZP1K7G. (7)

That was the initial investigationCronobacter sakazakii, a deadly bacterium, caused death. (7)

But Mead Johnson assured customers in a written statement that its products are safe:

„We are confident that all of our products are safe and nutritious when prepared, stored and used according to label directions.” (8)

During the investigation, things appear to have deteriorated for the company:

• While tests were being conducted at the deceased baby's home and on company premises, another baby died after allegedly drinking the formula. (7)(8)
• Two other babies in Illinois and Oklahoma were also infected, but both recovered. (7)(8)

Infant deaths angered many parents who had relied on Enfamil products. Sales plummeted when angry parents boycotted the brand. (7)

Pending the full results of the investigation, several retailers have recalled Enfamil Premium Newborn products or removed inventory from their shelves.

Walmart spokeswoman Dianna Gee made the following statement:

„As a precautionary measure, we have taken the company's decision to remove the specific batch of product from the shelves of our stores across the national territory. We are not saying the product is unsafe.”

But after several tests, the FDA (Food and Drug Administration) and the CDC (Centers for Disease Control and Prevention) have Mead Johnson Nutrition Co. and declared the products safe.

According to a joint statement by the two government agencies, their tests showed that unopened cans of Enfamil Newborn Powder Formulanotem Cronobacter. (7)

Authorities also announced that they found Cronobacter in the following samples: (7)

• An open container of baby food
• An open bottle of nursery water
• prepared infant formula

Because the unopened formulas tested negative for the deadly pathogen, authorities are unsure how the contamination came about. But he said it must have happened after the packages were opened. (7)

Therefore, even if the individual incidents involved the same formula, the authorities stated that there was no evidence that these infections were linked. (7)

„There is currently no evidence that infant formula or infant formula has been contaminated during manufacture or shipment..

Parents can continue to use powdered infant formula by following the manufacturer's directions on the printed label.”

Neither Mead Johnson nor the FDA have issued product recalls on the matter. (7)

Tim Brown, Mead Johnson's general manager for North America, later made the following statement:

„We're excited about the FDA and CDC testing, which should reassure consumers, healthcare professionals and retailers everywhere about the safety and quality of our products.” (7)

Mead Johnson, FDA and CDC reminded parents to follow safe practices and procedures when preparing and storing infant formula to avoid potential contamination. (7)(8)

Enfamil Gentlease Recall (2006)

In 2006, Mead Johnson called Gentlease powdered infant formula lot number BMJ19 with the "use by" code "1. July 07” back. Affected products may contain metal particles up to 2.7 mm in size. (9)

According to the recall warning, in the rare cases where the formula has been inhaled by the baby and reached the lungs, the metal particles can pose serious risks to the baby's respiratory tract and throat. (9)

Injuries or symptoms related to this issue are likely to occur within four hours: (9)

• Cough
• difficulty breathing
• difficulty swallowing

Consumers were advised to check the embossed lot number and expiration date on the bottom of the can. Individuals affected by the recall should immediately stop using the product and call Mead Johnson at 888-587-7275 for further assistance. (9)

Mead Johnson announced that as of December 16, 2005, approximately 41,464 cans of lot number BMJ19 had been distributed in retail stores in the United States. Fortunately, no illnesses or health incidents were reported. (9)

Recall EnfaCare LIPIL (2004)

Mead Johnson has recalled 505 cases of EnfaCare LIPIL as possibleEnterobacter sakazakiiContamination. (10)

According to the recall notice, the pathogen can cause the following fatal conditions in newborns, especially in immunocompromised or premature babies: (10)

• sepsis (bacteria in the blood)
• Meningitis (inflammation of the meninges)
• Necrotizing enterocolitis (a serious intestinal infection)

The recall alarmed many parents as EnfaCare LIPIL was specially formulated for premature babies and newborns with special nutritional needs. (10)

Affected lot code BME01 with expiration date code "1JAN04". No other lots or products were affected by this recall and no illnesses were reported. (10)

Customers who purchased this formula were instructed to call the Mead Johnson Consumer Resource Center at 888-587-7275 to exchange the formula. (10)

Enfamil Nutramigen Recall (2001)

In 2001, Mead Johnson Nutritionals recalled 4.6 million doses of ready-to-use and powdered Enfamil Nutramigen due to incorrect preparation instructions in Spanish. (11)

Incorrectly following these instructions can lead to serious health problems, especially if the formula is taken over several days: (11)(12)

• cardiac arrhythmia
• seizures
• Possibly to death

Babies who are already sick or who live in hot climates are at greater risk of potentially life-threatening complications. (12)

This formula was distributed in the United States, Guam, Puerto Rico and the Dominican Republic. (12)

This recall affected 3.7 million cans of formula powder (16 ounces) with the following lot codes: (11)

• BHC43
• BHC44
• BJC45
• BJC46
• BJC47
• BJC48
• BKC49
• BKC50
• BLC51
• BLC52
• BLC53
• BMC54
• BMC55
• BMC56
• BAM57
• BAM58
• BBM59
• BBM60
• BBM61
• BCM62
• BCM63
• BCM64
• BDM65
• BDM66
• BEM67
• BEM68
• BEM69
• BEM70
• BEM71
• BEM72
• BFM73
• BFM74

It also affected 930,000 ready-to-use cans (32 ounces) with these lot codes: (11)

• MBM90
• MBM91
• MCM92
• MCM93
• MCM94
• MDM95
• MDM96
• MEM97
• MFM00
• MFM01

In some places, retailers were allowed to resell the recipe. Nevertheless, the correct preparation instructions should be included as tear-off sheets that the customer can see immediately. (12)

Baby food shortage in 2022

Updated May 5, 2022

Ömassive recall from Similacin February 2022 exacerbated the infant formula shortage that has plagued the US since 2021.

According to research firm Dataassembly, it's up to 30%popular baby food brandsare sold out in the US, with some states like Minnesota being the most successful at 54% (out-of-stock percentage). (13)

A spokesman for manufacturer Enfamil, Reckitt Benckiser Group PLC, announced that the company had increased production. They are now shipping 30% more than they normally produce to help solve the shortage. (14)

The company said the shortage was hit by a surge in demand, much more than the infant formula industry anticipated. According to Reckitt Benckiser, sales rose 17%, more than double the predicted birth rates and other indicators. (14)

On April 29, 2022, Abbott Nutrition announced that it was releasing limited quantities of certain metabolic nutrition formulas at the request of the FDA. These include Similac PM 60/40, Calcillo XD, Ketonex 1 and 2, Glutarex 1 and 2, and Propimex 1 and 2. (15)

The company clarified that these products were not part of the recalled lots. All have been tested to meet product release requirements. (fifteen)

However, Abbott does not publish Similac,Food, zEleCare-Pulverformelnnot yet (these products were voluntarily recalled in February). Therefore, the release of these metabolites is not expected to solve the ongoing shortage of formulas. (16)

Reckitt Benckiser expects the milk shortage to last into the spring

Updated December 4, 2022

The formula shortage crisis is still lingering in the US a year after it began, despite formula manufacturers' efforts to increase production and government strategies to increase air formula supplies around the world. (17)

However, according to Reckitt Benckiser, the maker of Enfamil, things aren't getting better anytime soon. The company assumes that the crisis will last until spring. (17)

Reckitt Benckiser, which is now No. 1 in the US as the largest formulator (previously owned the ailing Similac), has increased production by running formula plants around the clock. However, due to increased demand, the supply of formula food on the market remains low. (17)

Abbott Plant reopens after flooding

Updated: July 11, 2022

The Abbott factory, which was shut down due to severe flooding in Sturgis, Michigan, has finally reopened after three weeks. The factory resumed production of EleCare shortly after reopening on July 1, 2022 and will soon be producing specialty and metabolic formulas. (18)

Overseas formulas beyond scarcity

To prevent the crisis from happening again, the FDA plans to allow imports of foreign formulas from temporary importers to continue shipping past the shortage. (19)

Official guidance will be released in September to detail how companies can meet FDA requirements to continue shipping formulas beyond mid-November. (19)

FDA receives new report of possible infant formula-related deaths

Updated June 22, 2022

On June 10, the FDA received a report that an infant had died in January, possibly as a result of consuming Abbott Nutrition's formula. (20)

Federal authorities have launched an investigation into the baby's death. (20)

US imports baby food from Mexico

Operation Fly Formula continues to bring more formulas from factories around the world whose products meet US standards. (21)

Its tenth mission will take Gerber Good Start Gentle Infant Formula from Mexico to Fort Worth, Texas starting June 24th. This particular mission will transport approximately 1 million pounds of formula, which is equivalent to approximately 16 million 8-ounce baby bottles. (21)

Formulas come from all over the world

Updated June 20, 2022

After President Joe Biden announced Operation Fly Formula, the program facilitated the rapid shipping of formulas from around the world and helped solve the US formula shortage.

Formulas sent in mid-June:

• 44,000 pounds (equivalent to approximately 548,000 8-ounce bottles) of Nestlé Health Science Alfamino and Alfamino Junior (specialty infant formula) arrived at Louisville International Airport (22) from Switzerland.
• 200,000 8 ounce bottles of Kendamil at Dulles International Airport, Virginia, UK (23)
• 95,000 cans (380,000 pounds, equivalent to approximately 4 million 8-ounce bottles) of Bubs Australia baby food arrived at LAX for Albertsons Companies, Walmart and The Kroger Company of Australia (22) (24)

More formulas should arrive by the end of June or from July:

• 750,000 cans of Danone formula (Aptamil First Infant Milk Stage 1) equivalent to 19 million 8 ounce bottles from the brand's facility in Ireland (23)
• 686,350 doses equal 16.5 million 8 fl oz bottles of formula (Similac NeoSure and Similac Total Comfort) from Abbott's plant in Granada, Spain (25)

Recalled baby formula sold in Canada

According to the CFIA (Canadian Food Inspection Agency), some Abbott baby formulas were accidentally sold by Shoppers Drug Mart due to an "online error." These were the same formula products that were recalled in February 2022. (26)

Anyone who has purchased Abbott formulas from the retail pharmacy giant is instructed to check their products for the following codes on the bottom of the box or container:

• The first two digits start with 22 to 37
• Code contains one of the following: K8, SH, or Z2
• Expiry date code starts in April 2022 or 4/1/2022 and subsequent dates

The retail pharmacy giant has announced the secondary recall of this infant formula, which the CFIA says should not have been sold to consumers. (26)

The newly opened Abbott factory closes again due to flooding

Troubles continue to plague Abbott Nutrition as the newly opened Sturgis plant was forced to close again due to Michigan flooding. (25)

The state experienced severe storms that caused power outages and flooding, causing damage to some areas of the Abbott facility. (25)

The company announced that production of the formula will again be delayed by a few weeks.

A comprehensive test with an independent third party must be completed before the FDA will allow the facility to resume operations. Once they receive FDA approval, Abbott will resume production of EleCare before starting Similac and other infant formulas. (25)

Nine formula-related infant deaths during the FDA's Abbott investigation

Updated June 11, 2022

From December 1, 2021 to March 3, 2022, a total of nine infant formula-related deaths were reported when the FDA conducted its Abbott investigation. Two of those baby deaths were included in the four confirmed casesCronobacter sakazakiiInfections that led to Similac withdrawing its formulas in February. (27)

None of the genome sequences in the FDA investigations matched Abbott's formula products, but all of the fatalities were fed various Abbott powder formulas, including the following. (27)

• EleCare baby food
• Similac PM 60/40
• Similac Pro-Total Comfort infant formula (powder)
• Similac Total Comfort Soft Protein and prebiotic Easily digestible
• Similac progress
• Similac Pro Advance infant formula

Abbott resumes formula production and prioritizes EleCare

Updated June 6, 2022

According to Abbott Nutrition, the company restarted its Sturgis, Michigan facility on June 4, 2022. The facility was closed because it was the center of the major Similac recall in February. (28)

Abbott will prioritize EleCare and other special or metabolic formulas for babies with severe food allergies and digestive issues. However, these newly manufactured formulas are unlikely to hit market shelves before June 20th. (28)

The company clarified that it will take about three weeks for the products to reach consumers, but it will also resume production of Similac and other formulas as soon as possible.

It is believed that the reopening of the Sturgis plant will help alleviate the formula shortage problem and soon improve the supply of formulas in the market.

Foreign companies ship stock as formula shortage hits 70%

Updated May 31, 2022

Infant formula out-of-stock rates in the US have reached alarming levels, with retail data company Dataassembly reporting it hit 70% nationwide in the week ended May 22. (29)

While parents in the United States struggle to find formulas, foreign companies promise to send action to solve the crisis:

• Kendal Nutricare (maker of Kendamil) of the UK said the company would ship formula to fill about 100 trucks in the US over the next six months. (30)
• Bubs Australia will ship at least 1.25 million cans to the US. (31)

The FDA has assured formula makers that they will relax some regulations to ease imports and resolve the crisis as soon as possible.

Abbott plans to reopen the factory involved in the recall

Updated May 13, 2022

On May 12, 2022, the CDC (Centers for Disease Control and Prevention) announced that it had completed its investigation into Cronobacter infections associated with Abbott Nutrition products. No other cases were identified during the investigation. (32)

Even with the investigation closed, the FDA has established an Incident Management Group (IMG) to continue working on supply chain and food safety issues. (32)

Also, the recall is still in effect. It is the investigation that is complete.

With stock-outs rising to 43%, the FDA is working with manufacturers to increase shipments. (33)

One way to increase inventories is to reopen Abbott Nutrition's Sturgis, Michigan factory, which was involved in the massive Similac recall in February 2022. (34)

In a statement, Abbott Nutrition announced it could resume production in about two weeks, pending FDA approval. Once production begins, the company plans to initially produce the EleCare,Foodand metabolic formulas, then it's on to productionSimilacand other formulas. (34)

However, despite the reopening of the Sturgis factory, Abbott Nutrition estimates it could take six to eight weeks for formulas to hit shelves.

Abbott Nutrition recognizes its part in the baby food shortage but said it has improved systems and protocols at the facility.

Some of these improvements include the following: (34)

• Reviewing and updating education, training and safety procedures for employees and visitors
• Updated logs for water, cleaning and maintenance procedures
• modernization of the plant, e.g. B. Installation of hygienic, non-porous and easily washable floors

While it's not yet clear what impact this resumption of production might have on the formula shortage, Abbott Nutrition hopes it can help improve the formula supply in the marketplace.

The White House announces measures to fix the formula shortage

US President Joe Biden met with baby formula manufacturers and retailers, including Gerber, Walmart, Target and Reckitt, to discuss how to safely and quickly get more formula on store shelves to address the shortage. (35)

The White House also released the additional measures the administration will take to increase the number of formulas available without compromising your baby's safety: (35)

Increased supply from imports

While the US typically produces about 98% of the baby formula it needs, shortages in baby formula due to supply chain issues and recent recalls have severely reduced available products. (35)

To meet increased demand and reduced supply, the White House plans to increase imports from key sources such as Chile, Mexico, Ireland and the Netherlands. (35)

reduce bureaucracy

Manufacturers typically produce different sizes of formulas of the same type to meet demand, about 50% of which comes from the WIC program (Special Supplemental Nutrition Program for Women, Infants and Children). (35)

To streamline product offerings and increase production, the Biden administration has directed the USDA (United States Department of Agriculture) to coordinate with several states to allow WIC recipients to purchase the products in stock rather than on WIC-approved options to restrict.

Combating unfair market practices and price manipulation

President Biden called on the FTC (Federal Trade Commission) to use all available tools to identify, investigate and monitor illegal or predatory behavior, including price gouging and unfair market practices. (35)

According to the White House fact sheet, certain individuals or unscrupulous retailers are taking advantage of formula scarcity to buy or stockpile formulas from legitimate suppliers and then rebrand them for sale online to desperate parents. (35)

There have been reports of formulas typically selling for $43 to $47 and listing on eBay for up to $800 (36).

While retailers like Walmart, Target, and CVS have capped how much customers can buy, they're still running out of formulas. (36)

Biden relies on the Defense Production Act

Updated May 25, 2022

As the U.S. dairy food crisis worsens, Biden has invoked the Defense Production Act to urge suppliers to prioritize orders from infant formula makers. (37)

The first two Defense Production Act approvals are priority orders for manufacturers Abbott Nutrition (Similac) and Reckitt Benckiser (Mead-Johnson's Enfamil): (38)

• Abbott Nutrition's priority orders are raw materials, including sugar and corn syrup
• Reckitt's priority orders include filters and other disposables used in the manufacture of the oils needed to manufacture infant formula

These priority deliveries are expected to increase production for these two companies: (38)

• Once the Abbott factory resumes operations, production is expected to increase by a third.
• Reckitt factories can run at full capacity with these supplies.

Biden Launches “Operation Fly Formula”

Biden launched "Operation Fly Formula" to use military aircraft to import branded formulas that meet US standards to replenish shelves. (37)

These special flights can be shipped within 72 hours, while it would normally take two weeks for products to arrive in the US for a regular shipment. (39)

The first European shipment arrives in the United States

The first batch of formulas (78,000 lbs) for Operation Fly Formula arrived in the US. This includes special Nestlé baby food: 132 pallets of Alfamino baby food and Alfamino junior food. (38) (39)

It can supply 15% of the US's need for specialty medical-grade infant formula, said Brian Deese, director of the White House National Economic Council.

The products came from Zurich, Switzerland, but were picked up by a US military plane from Germany and taken to Indianapolis. These were taken to Nestlé's local distribution center about a kilometer away for standard quality control. (38)

These specific formulas were prioritized because of their scarce supply in the US and because they serve a critical medical purpose for babies with cow's milk protein allergy.

However, these medicinal formulas are not expected to hit store shelves. Instead, they will be sent to pharmacies, hospitals and doctor's offices in the most affected regions. (38)

According to Agriculture Secretary Tom Vilsack, this first batch can provide food for 9,000 babies and 18,000 children for about a week. (39)

More formula deliveries coming soon

Another flight of formula Gerber Good Start Extensive HA (114 pallets) from Europe is due to arrive in the coming days. (38)

This next shipment from Germany is expected to arrive in Pennsylvania, again for distribution by another Nestlé facility in the region. (38)

According to the White House, the first round of flights will yield a total of formulas equivalent to about 1.5 million doses in 8-ounce bottles. (39)

States hardest hit by lack of formulas

In April 2022, out-of-stock rates increased to 50% in the following states: (40)

• Tennessee
• Iowa
• Dakota do Sul
• Dakota do Norte
• Missouri
• Texas

In May, Nevada also saw its baby formula supply fall by at least 50%. (41)

House approves $28M emergency spending and bills for WIC flexibility

The US Congress passed two bills to solve the shortage:

• $28 million emergency spending bill
• WIC flexibility calculation

$28 million emergency spending bill

Democrats have proposed a $28 million emergency spending bill to increase FDA resources, including hiring more staff. This met with opposition from Republicans, with up to 192 votes against. (37)(42)

Democratic Rep. Rosa DeLauro, chair of the House Appropriations Committee, said this bill should increase FDA staffing levels so more people can do the following to improve formula inventories: (37)

• Check national and international suppliers
• Get better data on the market
• Prevent counterfeit products from reaching store shelves.

Although passed, the law received negative comments from Republican lawmakers:

• Rep. Bill Huizenga said more formula production is needed, not more FDA personnel. (37)
• The chair of the appropriations subcommittee that funds the FDA, Rep. Andy Harris, said it's not a question of money, it's a question of leadership. (43)
• Republican conference chair Elise Stefanik accused Biden of “leadership failure.” (42)

This budget measure is expected to face opposition in the Senate as Republicans question the FDA's apparent irresponsibility for the shortage. Many lawmakers are also investigating possible FDA violations that may have resulted in child deaths related to Abbott products. (44)

Representatives from the Republicans in the House of Representatives introduced a separate bill called the Babies Need More Formula Now Act to source formula from foreign sources. (42)

WIC Flexibility Act

Another bill will allow WIC participants to purchase any formula product from available suppliers, rather than being restricted by WIC-approved brands that may not be available. (43)(45)

It also gives the Secretary of Agriculture ongoing flexibility to issue similar waivers in the event of future supply disruptions. (43)(45)

The bill also requires formula manufacturers to create a contingency plan to protect against supply disruptions in the event of a recall. This can prevent a similar defect from occurring again. (43)

In contrast to the budget draft, this was quickly passed with a large majority of bipartisan votes in the House of Representatives and also in the Senate. Now it's up to Biden to sign that into law. (42)

FDA commissioner presents himself to Congress

During a May 2022 investigation into the infant formula shortage in Congress, Rep. Rosa DeLauro and other lawmakers urged FDA Commissioner Dr. Robert Califf on why it took several months to investigate a whistleblower complaint about Abbott plant safety violations. (46)

However, Califf said he could not share details of the FDA's ongoing investigation. (46)

He admitted that he had read the complaint but did not specify what steps were taken to resolve the issue immediately.

Lawmakers agreed with the FDA chief that the US formula market is prone to disruption because it is dominated by a handful of players.

Up to 90% of the US formula market is owned by: (46)

• Abbott (similar)
• Gerber
• Perrigo (parents' choice)
• Reckitt Benckiser (Mead-Johnsons Enfamil)

These four companies also have federal contracts for the WIC program for low-income families, which actually accounts for 50% of US formula production. (46)

Therefore, it is easy to see that major disruptions in supply to these companies will directly affect the supply of formulas on the market.

Abbott Nutrition used to be the market leader with a 40% share, closely followed by Enfamil. However, following the Abbott recall and plant closure, Reckitt Benckiser now holds the top position with an estimated 50% market share. (47)

To meet the increased demand, Enfamil increased production by 30%. (47)

FDA Abbott Court Consent Decree required prior to return of production

Abbott must comply with a court consent decree filed with the U.S. District Court for the Western District of Michigan between the company and the FDA before production can resume: (48) (49)

• Cleaning and disinfection facilities, including all equipment
• Reboot all devices to run tests
• Conducting various tests
• Checking all ingredients
• Hire an external expert to independently review your processes

The company must also review and amend the following: (48)

• Environmental Monitoring Program
• Product sampling and testing plans
• training programs for employees

To avoid a repeat of the previous issues that led to the recall and missing formula, the court's consent decree also requires Abbott to immediately cease production and notify the FDA if contamination is found. (49)

Abbott is taking "serious action" to address the formula shortage

Abbott CEO Robert Ford detailed the "serious steps" the company is taking to address the formula shortage. He also apologized for the company's role in the crisis. (50)

Because Abbott has up to a 40% share of the formula market, the Sturgis plant was shut down after the recall exacerbated shortages that began in 2021. (51)

To address the infant formula shortage, Ford is taking these "serious steps," according to Ford: (50)

• Conversion of adult nutrition product lines to ready-to-drink liquid infant formula manufacturing at an Abbott facility in Columbus, Ohio
• Acceleration of production processes
• "Strict controls" of the products
• A $5 million fund for families with babies hospitalized because they don't have access to special formula
• Air transport of millions of the company's most commonly used powdered infant formulas from an FDA approved facility in Ireland

Ford has also reassured consumers that once production resumes, they will: (50)

• More than double the production
• Invest in improving security
• Improving the quality of processes and facilities
• Make significant investments so that the formula crisis does not happen again

Ford added that he issued the formula's voluntary recall because he didn't want to endanger the babies' lives or health.

He clarified that none of the bacterial strains sequenced from the reported infections were found in Abbott's retained products. (50)

The FDA rejects Abbott's claim of different strains of bacteria

According to Abbott, the sick babies' bacterial strains did not match those taken from the Abbott factory in Sturgis, Michigan, based on the FDA investigation. (37)

However, FDA officials recently refuted Abbott's claim. (37)

Chief Food Officer Susan Mayne explained that they were unable to establish the link between Abbott's products and the babies' cases because they only received sequences from two babies. (37)

They couldn't get samples from the other babies.

Abbott buyback program and high profits while the facility needed repairs

Groups like the Groundwork Collaborative, a progressive trade association, have criticized Abbott for posting record profits of up to 94% between 2019 and 2021, the same period that bacteria were found in its products. (52)

Abbott's net income increased to $7.1 billion from $3.6 billion two years before the recall, according to Securities and Exchange Commission filings. (52)

The company also increased dividends by more than 25% and offered shareholders a $5 billion share buyback program. (52)

Rakeen Mabud, chief economist at Groundwork Collaborative, said the company chose to enrich shareholders rather than improve its facilities and make productive investments. (52)

Moe Tkacik, senior fellow of the American Economic Liberties Project, pointed out that until 1982, buybacks were illegal and considered a form of manipulation. (52)

Tkacik also believes that restrictions should be imposed on companies like Abbott that receive federal funding or whose largest customers are federally funded programs like the WIC. (52)

However, Abbott claims that the safety of its product has not been compromised by the buyback program. Even with the share buyback, the company with its "solid balance sheet" still manages to improve its equipment. (52)

Senate investigation into Abbott's buyback program

The Senate Treasury Committee plans to investigate Abbott's stock buyback program and review investments to improve plant safety, which have generated record sales. (44)(52)

Possible criminal charges for lack of baby food

Who is to blame for the baby food crisis?

House Speaker Nancy Pelosi believes an indictment may need to be brought to prevent a similar crisis from happening in the future. However, she wants to do so after nationwide infant formula shortages are resolved. (53)

While she did not provide the details of the possible criminal charges, Pelosi clarified that they are not connected to any of her colleagues. (53)

Some babies were hospitalized for lack of infant formula

Some babies, many of whom needed special formulas like Elecare because they couldn't digest complete proteins, have been hospitalized in different parts of the US amid the crisis.missing formula.

Children depended on the protein building blocks called amino acids in EleCare because these smaller protein components did not need to be digested.

Since EleCare was included in Abbott's recall in February 2022, these children had to try other formulas. Most of them could not tolerate the new options, leading to dehydration and malnutrition. (54)

Finding the right formula can be difficult for children with these conditions. The new one shouldn't cause any potentially dangerous reactions (such as dehydration or diarrhea), but it should meet your dietary needs.

There were also babies who had no medical problems but were hospitalized due to an intolerance to the new formula they were taking. Others have experienced mineral imbalances after taking homemade formula.

Data from various hospitals across the US showed that several children were hospitalized for lack of formula:

• Tennessee -Two children were hospitalized at Le Bonheur Children's Hospital in Memphis, Tennessee for lack of EleCare (both were unable to absorb normal-sized proteins). (54)
• Carolina do Sul -Three babies were admitted to Shawn Jenkins Children's Hospital at the Medical University of South Carolina in Charleston for intolerance, while one was hospitalized for a mineral imbalance after taking homemade formula. (39)
• Georgia –An unknown number of infants and some older children were admitted to Children's Healthcare in Atlanta, Georgia, for malnutrition. They had special dietary needs and cannot tolerate new formulas. (55) (56)
• Wisconsin-Several children (the exact number was also not disclosed) were treated for malnutrition at Children's Wisconsin after taking inadequate substitute products or homemade formulas. (56)

Children's Wisconsin warns parents that homemade formulas can cause liver and/or kidney damage. This can also cause the baby's heart to stop due to imbalance.(56)

Diluted formulas can also cause brain swelling or organ failure.(56)

Safe preparation and storage of the formula

The CDC recommends reading the directions on the formula container carefully. Different formulas may have different requirements or instructions for: (57)

• How many spoons do you need to brew a given amount of water?
• Storage Instructions

When preparing and storing baby food, you should also observe these safety precautions: (57)

• Always wash your hands with soap and water before preparing bottles and feeding your baby.
• Prepare your baby's formula on a clean, sanitized surface.
• Keep bottles clean and sterilized. It would be best to keep these items away from high-traffic areas in your home.
• Always use water from a safe source when preparing any formula. Contact your local health department if you are unsure about the safety of tap water.
• Use only the correct amount of water listed in the formula instructions. Not enough water can cause your baby to become dehydrated or overwhelm the digestive system and kidneys. But too much water can result in a formula that doesn't meet your baby's nutritional needs.
• Always keep the formula container tightly closed and store in a cool, dry place indoors.
• Most formulas must be used within a month of opening.
• Always check for discoloration, strange odors, or signs of contamination before preparing a bottle.
• Always check the expiration (expiry) date. Never use an expired formula.
• Use a prepared formula within two hours of preparation or one hour after beginning feeding.
• You can keep the premixed bottles in the fridge for 24 hours, but only if your baby hasn't started feeding them yet.
• Used or leftover formula should be discarded after each feeding, even if there is still plenty of liquid in the bottle. The combination of your baby's saliva and the formula can cause bacteria to grow in these scraps.
• Never give your baby formula a batch or a batch that has been recalled due to contamination or other safety issues.

What to do if your baby is deprived of infant formula or formula

after anyrecall formulaorfood recallDisplay, do the following:

• Check the product name, lot number or lot code, and expiration date or expiration date.
• If the product you own is part of the recall, stop giving it to your baby immediately and contact the manufacturer or store for refund or replacement procedure.
• Call your pediatrician if your baby shows signs of an upset stomach or other medical problems from drinking the recalled product.

Formulas or products that have not been recalled

The following formulas were not retrieved:

• Similac Pro-Advance Non-GMO Infant Formula with Iron
• The best non-GMO soy-based infant powder formula in the world
• Kabrita goat milk powder for infant formula
• Else Complete Plant-Based Nutrition for Babies
• Enfamil Neuropro
• Enfamil A2 with prebiotics
• Happy Baby organic starter food
• Enfamil Enspire baby food with iron
• Meyenberg whole goat milk powder, gluten-free

However, always consult your pediatrician before starting or switching formulas.

Recalls of other brands and products of infant formula

Baby food recall in 2022

Recall of Similac ready-to-feed liquid products

Updated October 16, 2022

In mid-October 2022, Abbott Nutrition voluntarily recalled some lots of the following ready-to-eat liquid products (2 fl oz or 59 ml bottles) due to leaking caps that could lead to potential spoilage: (58)

• Similac level 1
• Similac NeoSure
• Similac 360 all-round care
• Similac 360 Total Care Sensitive
• Similac special care 24
• Similac Pro-Total Comfort
• Similac water (sterilized)
• Pedialyt electrolyte solution

Only these products and lots are affected by this recall.(Read ourSimilac souvenir itemsfor list of vial and carton lot numbers)(58)

According to Abbott's recall notice, babies may experience vomiting, diarrhea, or gastrointestinal symptoms when fed these tainted products.(58)

Do not feed your baby these recalled products.

For more information, contact Abbott Nutrition at this number:

• USA: 1-800-986-8540

Reminds me of da Similac

Updated March 29, 2022

• On February 17, 2022, Abbott Nutrition rememberedSimilac,Food, zshe whichPowdered infant formula due to possible contamination with bacterial strainsCronobacter sakazakiiesalmonella🇧🇷 A baby would have died from itCronobacterInfection after allegedly drinking Similac formula. Affected are batches with codes containing K8, SH or Z2, where the first two digits of the codes start from 22 to 37. (59)
• On February 28, 2022, the company announced another recall: Similac PM 60/40 with lot #27032K80 (can) or lot #27032K800 (box) following the death of a second baby related to this formula. (58)
• The FDA reportedly found several safety issues during its inspection of the factory, including a lack of temperature controls, unsanitary conditions and workers not properly following safety protocols. (59)
• This massive recall has made it worseUS Formula Shortage.

Formula Angel Recall

On January 7, 2022, the FDAreminded of the angelic formula "Healthy Beauty"from Moor Herbs for non-compliance with safety requirements for infant formula: (60)

• No pre-marketing notifications to the FDA
• May contain levels of iron, potassium, and sodium much higher than maximum limits (the FDA recall notice did not disclose their testing levels)
• The product does not meet FDA labeling requirements because it does not have a UPC (Universal Product Code) or manufacturing lot code.

What baby food is in the 2021 recall?

Below are some of the recalls from other formula brands:

Able Groupe Baby Formula Recall

• Able Groupe collected all batch codes fromHiPP, Holle, Kendamil, and Bioland (Lebenswert) in August 2021 for failing to meet FDA requirements for premarket reporting, minimum iron levels, and proper labeling (for potential iron supplements). (61)
• These are European formulas imported from LittleBundle. (61)
• According to the recall notice, regularly feeding your baby formula low in iron (below the minimum of 1 mg of iron per 100 calories) can lead to iron deficiency anemia. This condition can lead to irreversible cognitive or functional developmental outcomes. (61)
• For processing returns or refunds, customers have been instructed to get in touch[email protected]

Designed by Nature Recall

• The FDA withdrew all Designed by Nature baby food products (base formula, goat and cow milk) on June 14, 2021. potential health risks from incorrect labelling. They are not intended for use as infant formula, but the labels do not state this. (62)
• The company also admits it does not test for the presence ofCronobacter,which can be dangerous, even fatal, for babies. (62)

Other formulas remembered in earlier years:

Kirkland Signature Brand Non-GMO Lactose Sensitive Infant Formula (Kanada)

• Costco Wholesale Canada Ltd. recalled the formula on October 25, 2019 for possibleCronobacter spp.Contamination in products sold in Costco stores in Canada. (63)

• The recall affected batch codes EXP 2020 NO 05 T05DVBV (1.36 kg) and EXP 2020 NO 05 T05DVBV (2 packs, 2 x 1.36 kg). (63)

Calcilo XD formula recall

• On September 17, 2019, Abbott Laboratories recalled Calcilo XD Powder Jars (13.2 oz / 375 g), lot number 79696K80, due to inconsistencies in the odor and color of that particular lot. (64)

Recall of Similac TummiCare One Infant Formula (Philippines)

• Abbott Laboratories recalled this formula on August 14, 2019 in the Philippines due to differences in the size of the preparation spoon and the label directions. This only affected batch #03518QU. (65)

• The product itself is safe to consume. However, improper preparation of the formula with the spoon (included in the pack) may not provide enough nutrients to support normal growth. (65)

Parent's Choice Advantage Infant Food Recovery

• Perrigo Company plcrecalls Parent's Choice Advantage infant formulaon June 21, 2019 for possible metallic impurities. This affected only one batch with batch code C26EVFV and an expiration date of February 26, 2021 (35 oz, 992 gram container).(66)

• You can speak to the Department of Consumer Protection if your formula is affected by this recall. (66)

Store recall of Milupa Aptamil 1 Pronutra (Slovenia)

• Retailer Mueller Drogerija recalled this Danone formula in August 2018 after a customer in Slovenia found some dead bugs in a bottle of this formula. (67)
• The recall affected the 800 gram pack with item number 100762029 and date 10/13/2019. (67)

Dumex Mamil Gold Infant Formula (Step 1) Recall in Singapore

• Dumex has recalled this formula (850g) with lot number 09117R1 and expiry date 9/11/2019 due to possible contaminationCronobacter sakazakii. (68)

Bebe Almonds Stage 2 (Organic) Recall

• La Mandorle recalled this product on November 5, 2018 due to possible contamination with the deadly bacteriaCronobacter sakazakii. (69)

Lactalis Nutrition Health (LNS) recall.

• On December 2, 2017, Lactalis Nutrition Santé (LNS) withdrew Picot AR, Celia, Milumel and Taranis brand formulas due to possible contaminationSalmonella agona. (70)

• The formulas were made on February 15, 2017 in Craon, France. Contaminated formulas can cause gastrointestinal upset, vomiting, diarrhea, headache, chills, fever, and abdominal cramps. (70)

Gerber Good Start Soy Formula (Adult)

• In May 2017, a two-month-old child was hospitalized in Arizona after aGerberI'm a good starting formula that may have been tampered with. (71)
• Police arrested Jennifer LaPlante for the incident. She reportedly replaced the contents of the formula with wheat flour, sugar or rice flakes before returning it to the store for a refund. (71)
• Geber decided against a recall as this was considered an isolated case. (71)

Recall of Sammy's Milk baby food (powder for infant formula)

• In September 2016, the FDA recalled this formula from Graceleigh, Inc. for non-compliance with infant formula regulations. The product is low in iron and not tested for lethalityCronobacterpathogen. (72)

Why was Similac recalled?

• Abbott Laboratories Inc.remembered several Similac formulasin 2010 due to possible contamination with larvae or adult adults of the small common beetle discovered at a factory site in Sturgis, Michigan. (73)
• This recall affected up to 5 million packs of Similac infant formula. (74)

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