(first recall), and Similac PM 60/40 (second recall). (35), Before the recall and formula shortage, 90% of the US formula market is dominated by just four players: (35), Not surprisingly, these four companies also dominate the federal contracts for the WIC program intended for low-income families. FDA Infant Formula Update: June 2, 2022 For Immediate Release: June 02, 2022 Espaol Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that. gerber oatmeal recall 2022wvu mechanical engineering research. (4). They didnt issue any recall on the formula. Supplements & Vitamins Formula Baby Cereal Baby Food Snacks Meals & sides Beverages Organic. (20). The baby had consumed Similac PM 60/40 from this lot. Gerber Introduces Plant-tastic The Brand's First Complete Range of Organic, Plant-Protein Foods April 21, 2022 Today, early childhood nutrition leader Gerber announced Plant-tastic, the brand's first complete range of organic-for-toddler, plant-protein foods. The following results are also from the Healthy Babies Bright Futures report, too: (3), According to the Congressional Report, the company never responded to the Subcommittee. According to FDA Commissioner Dr. Robert Califf, the new deputy commissioner for human foods will have clear decision-making authority, ensuring the US food supplys safety. However, Abbott Nutrition estimates that it could take six to eight weeks before these formula products hit the shelves from the Sturgis plants reopening. It carried a total of 132 pallets of Nestle Health Science Alfamino Infant and Alfamino Junior formulas. (52)(53), According to the report, Twitter posts about homemade baby formula rose as much as 2,100% (around 5,000 tweets) from the first to the second week of May. Overview Searching for a milk formula for your little one, but unsure which one to pick? As the baby formula shortage continues to rage in the US, US President Joe Biden invoked the Defense Production Act to help address the problem. (72), In August 2019, Abbott Laboratories recalled this formula in the Philippines due to differences in the label instructions and preparation scoop size. (29). The specialty formulas are being prioritized because theyre needed by children with cows milk protein allergies who cant just use regular formulas. (8), Recently, Enfamil maker Reckitt Benckiser forecasted that the crisis will persist until spring despite the company ramping up products and operating its formula factories 24/7. It was done following the death of another infant who tested positive for Cronobacter sakazakii. We trust these companies with our babies, and they have failed us., The following are the affected baby food products, based on test results submitted by the companies or third-party organizations: (4), The company declared to the Subcommittee that it doesnt test the finished products for heavy metal content. (50), The division chief for Pediatrics at Spectrum Health, Dr. Hanna Jaworski, explained that cows milk could be a better option than watered-down formula. Cronobacter infections can be deadly, especially to newborn babies. Though manufacturers can implement strict safety measures, there are times when contamination or safety issues happen. Because heavy metals and other contaminants could greatly affect babies body and brain development, Consumer Reports and the US PIRG (Public Interest Research Group) call for the passing of the Baby Food Safety Act of 2021. (6), The consumer protection branch of the US Justice Department has reportedly put Abbott under criminal investigation over the companys possible role in the formula shortage. Bubs Australia announced that it will send at least 1.25 million cans of baby formula to the US, while also assuring Australian parents that they have enough stocks for everyone. (4). (42), After learning about this, the Senate Finance Committee announced that theyre going to investigate Abbotts investments and the reported stock buyback program. Learn More. (92)(93), In 2006, Gentlease powdered infant formula (lot number BMJ19, best before date code of 1 Jul 07) was recalled due to possible metal particle contamination. (40), Although Abbott maintains that the bacterial strains from their plant didnt match those from the FDAs investigations, FDA officials recently refuted this claim. Find out more about these recalls and tampering issues below. (4), According to the Subcommittee report, Hain admitted that its only using theoretical calculations, not actual test results. In February Abbott Nutrition recalled their Similac, Alimentum and EleCare formulas after four infants fell ill and two infants died, leading to concerns about bacterial contamination in the. It accounts for 50% of US formula productions. (4). Recent findings in inspections conducted from January 31 to March 18, 2022, showed that the same safety concerns as the September 2021 report were observed inside the factory. (95), Although it doesnt pose an immediate health risk, babies who dont receive enough vitamin C may experience deficiency. This recall doesnt include Abbott liquid formulas, any metabolic deficiency nutrition formulas, or other nutrition products made and sold by the company. These amino acids dont have to be digested. Abbott Nutrition announced that production could restart in about two weeks (or by the end of May), subject to FDA approval. Check for local resources. (59), Whistleblower Told The FDA About Abbotts Security Lapses Months Before Recall, Hid information during a 2019 FDA audit (he claims the managers may have sanitized files). But the company encourages everyone to check the package appearance before purchasing any of their products. KNOXVILLE, Tenn. (WVLT) - As the Abbott Nutrition recall widened, many parents are searching for alternatives that may not be traditional. Dont pay using money transfer, gift cards, or cryptocurrency. But after shaking the bottles, she was surprised when the powder still didnt dissolve. A review of the firms internal records also indicate environmental contamination with Cronobacter sakazakii and the firms destruction of product due to the presence of Cronobacter. (4), The FDA explains that Cronobacter can cause severe, life-threatening infections. (103), Formulas are recalled if they dont meet the FDAs standards. They put their money to help the shareholders instead of improving the plant or making productive investments. But did the new report lead to a recall of the affected Gerber baby foods? They want answers, and for the FDA and Abbott to find the root cause of the problem to ensure that infant formula contaminations wont happen again. The federal agency also failed to issue a safety notice or recall of these products, which might have stopped the contamination that led to at least two reported infant deaths and eight hospitalizations. The kids were admitted to the Medical University of South Carolina Shawn Jenkins Childrens Hospital in Charleston, South Carolina. In December 2017, Lactalis Nutrition Sant (LNS) recalled products from Picot AR, Milumel, Celia, and Taranis for possible contamination with, The possibly contaminated formulas can cause gastrointestinal problems, vomiting, headaches, chills, diarrhea, fever, and abdominal cramps. Instead, the money might be better spent on increased formula production. It is believed that Abbott Nutritions reopening of its Sturgis, Michigan plant, the one involved in the massive Similac recall in February 2022, might boost the stocks. However, theyre still running out of baby formulas despite these measures. They cleared Mead Johnson Nutrition Co. (43), While the nationwide out-of-stock rate was around 40% in April 2022, it soared to 50% in the following states: (44), Sometime in May, Nevada announced that its also experiencing a decrease of at least 50% of the states baby formula supply. (85), In September 2016, the FDA recalled this formula by Graceleigh, Inc. for failing to meet infant formula regulations. Its a stipulation added so that the possible contamination and massive recall wont happen again. (4), for close to 20% of Nurture vegetables and, declared that all its raw materials passed, . Nutricia Tests Positive For Cronobacter In Australia, tested positive for Cronobacter (a type of bacteria also involved in the, ) during routine screening by Australian customs. (99), Affected products include 3.7 million cans of powder formula (16-oz) with the following lot codes: (98), The recall also affected 930,000 cans of the ready-to-use version (32-oz) with these lot codes: (98), In some places, the retailer stores were allowed to continue selling the formula. Yet, the actual results are still several times higher than the FDA standards. Those formulas have since been recalled and removed from shelves. He explained that the bacteria found at their plant didnt match those found in the affected babies samples, but they issued the voluntary recall to reduce the risks to childrens lives and health. (27), Several groups are calling out Abbott for reportedly enjoying high profits (as high as 94%) between 2019 and 2021, even if bacteria were already detected in its products within the same period. In the middle of June, as many as 95,000 cans of baby formula arrived in LAX from Australia for Albertsons Companies, Walmart, and The Kroger Company grocery stores. Affected products were from lot code BME01 with an expiration date code of 1JAN04. There werent any other lots or products affected by this recall. (82), Upon checking the powder in the container, she realized that the consistency and color of the product were different from the formula she usually buys. (31), After the Similac recall, Enfamil now feeds around 211,000 more babies than it had before the formula shortage began. (54). The plants reopening is expected to help improve formula supplies in the market and, hopefully, solve the formula shortage problem soon. To further increase the market supply in the US, the company representative added that theyre checking for ways to tap into the Nestle global nutrition network to import other formulas. This sheds a little more light on what went wrong, but we still dont have all the answers. Although Pelosi didnt specify the details of the possible criminal charges, she clarified that her remarks arent associated with her colleagues. To assure worried customers, Abbott Nutrition explained that they had improved their systems and protocols at the Sturgis facility. The recall affects about 145,000 12.9-ounce containers manufactured between August and September 2022 and distributed through retail stores in the U.S., Guam and Puerto Rico. (96), According to the recall advisory, the deadly pathogen may cause the following conditions in newborns, particularly premature babies and infants with weakened immune systems: (97), This recall alarmed many parents because the product is especially formulated for premature babies or newborns with special dietary requirements. (45), The FTC (Federal Trade Commission) warns desperate parents against paying hefty prices for formulas through fraudulent online stores, explaining that scammers are taking advantage of the situation. The whistleblower alleged that Abbott Nutrition: (60)(61), The whistleblower also claims that he sent this report to the FDA in October 2021, months before the babies deaths and the February 2022 Similac recall. An administration official explained that the specialty formulas arent set to hit retail store shelves because theyre specialty products that are best sent to the medical facilities first. (12), Troubles continue to hound Abbott Nutrition as its Sturgis plant closes again just days after reopening due to floods affecting the area. Only the raw materials are tested. (29), According to the White House, as many as 50% of the formula manufacturers production goes to the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). Symptoms of meningitis and sepsis can include the following: (4). (30), The brand has also increased production and announced that theyre working round the clock to help solve the shortage and meet the increased demands. (84), Gerber Good Start Soy Formula (Possible Tampering), In May 2017, a two-month-old baby was rushed to a hospital in Arizona after consuming a, Good Start Soy formula, which was believed to have been tampered with. or use the appliances you already have in your kitchen in preparing your babys food. can also have high levels of lead and cadmium. EleCare production will resume after re-sanitization and the FDAs approval to resume production. It didnt look or smell like the formula she regularly bought for her baby. They remind parents and caregivers to follow the instructions on the packaging for proper handling, preparation, and storage of all powder formulas to avoid any contamination. (75), After conducting separate investigations, Enfamil and Publix assured customers that it was an isolated incident. (7), that may result in product spoilage during handling and transport. Instead, these baby food companies created internal standards with increased limits. Pallets of Nestle's Gerber Good Start Extensive HA formula are unloaded from a FedEx Express aircraft after arriving to Dulles International Airport in Dulles, Virginia, May 25, 2022. (68), According to the FDAs recall advisory, regularly feeding your child with a formula with low iron levels (below 1 mg iron per 100 calories) can lead to iron deficiency anemia. (28). (18), Similac Pro-Total Comfort (Powder) infant formula, Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics, Abbott Reopens Sturgis Plant, Starts EleCare Production, Foreign Companies Help As US Formula Shortage Hits 70%, Babies Hospitalized In The US Due To The Formula Shortage, Babies Hospitalized In South Carolina For Intolerance & Mineral Imbalances, Undisclosed Number Of Kids Hospitalized in Georgia, Undisclosed Number Of Kids Hospitalized in Wisconsin, Defense Production Act Invoked To Address Shortage, For Abbott Nutrition raw materials (e.g. Abbott clarifies that distributed products in the recent recalls (Similac PM 60/40 and the previously recalled Similac, Alimentum, and EleCare powdered infant formulas) all tested negative for the presence of Cronobacter sakazakii. Symptoms can include irritability with generalized tenderness. (94), According to the FDA advisory, premature babies fed with this formula may have a higher risk of developing iron-deficiency anemia. (24), Social media platforms are scrambling to remove or label these baby formula recipes. According to the spokesperson, they admitted babies to older children. (89), It affected over 5 million Similac infant formula containers. Enfamil Gentlease in 2006 for metal contaminants (96), Enfamil EnfaCare LIPIL in 2004 for Enterobacter sakazakii contamination (97), Enfamil Nutramigen in 2001 for potentially dangerous label errors (98)(99), Parents Choice Rice Baby Cereal was recalled on October 8, 2021, for having inorganic arsenic content higher than the government standards. (49), However, since these formulas are still unregistered, the FDA reportedly continues to crack down on sellers offering these products. (51), Jaworski recommends choosing cows milk over homemade formula or diluted formula but added that this should only be as a bridge for a day or two until you can find your preferred formula. Aside from the videos raised by Bloomberg, YouTube also removed content that sells, promotes, or provides instruction for making homemade baby formula under their Harmful & Dangerous policies. (82), The company conducted an internal review and later declared it an isolated incident. 2022 Baby Formula Recalls Abbott Similar Ready-to-Feed Formula On October 17th, Abbott recalled their 2-ounce ready-to-feed formula bottles. (75), She prepared a new batch of formula the following morning, but her husband noticed that the contents immediately separated when they prepared a fresh bottle. In June 2021, Designed by Nature baby formula products (base formula, cow milk, and goat milk) were recalled for possible health and safety risks due to incorrect labels. Many were at dangerous levels, higher than the limits set by the FDA (U.S. Food and Drug Administration). So, which products were affected by the formula recalls, and why were they recalled? (24), Danone SA, the makers of Aptamil based in Paris, France, announced that it has increased its formula shipments to help with the US shortage. (9), The FDA plans to allow the import of overseas formulas from temporary suppliers to go beyond the shortage to prevent it from happening again. The House recently passed two bills to address the shortage: One bill grants the USDA (Department of Agriculture) secretary the permanent flexibility to issue waivers in supply disruptions so that WIC participants can buy any formula from available suppliers. (84), The formulas had a manufacturing date starting from February 15, 2017. The following products (all lot codes) were included in the recall: (68). (19). Overview Searching for a milk formula for your little one, but unsure which one to pick? Some of these are from pesticides. Its the one involved in the recent Similac recall over several safety issues. It was followed closely by the long-time number 2 baby formula brand in the US, Enfamil. (72), Only the batch with lot number 79696K80 was affected. Abbott and the FDA really need to do more work to get to the bottom of what happened so we can prevent the next outbreak. Considering the deaths and hospitalizations of several infants linked to the possible contamination, something must be done to correct this serious safety concern. (Read our Similac recall article for the list of affected lots). (4), in ingredients from rice flour (67 batches), The company doesnt test the other raw materials or ingredients for this, , only Nurture regularly tests ingredients, arent used as a basis for product release. But the company had set very high internal maximum levels, so the ingredients actually failed government regulations. The product also failed to meet the FDAs labeling requirements because it doesnt show a UPC (Universal Product Code) and a manufacturing lot code. The company also clarified that these products are available in limited quantities because production hasnt resumed yet at the Sturgis facility. Consult your pediatrician if your baby shows signs of stomach upset or other medical issues from drinking the recalled product. The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if the first two digits of the code are 22 through 37; the code on the container contains K8, SH or. (100), Beech-Nut Single Grain Rice Cereal was recalled on June 8, 2021, for high arsenic levels, too. (63). The group pushes for a ban on buybacks, putting limits on shareholder dividends, and stricter antitrust enforcement. Because of their lapses, the possibly contaminated formula produced in the factory may have caused the death of the two babies. So, any changes to their formula have to be carefully monitored for tolerance or they could end up getting sick. Also, the company insists that its products arent the source of the infections based on internal investigations. (51). powder . Mead Johnson (Enfamils manufacturer) sent her a shipping box so they could test the product. (89), The issue was discovered during a quality review. FDA officials explained that even if the Abbott plant in Sturgis will reopen, the company needs to comply with various requirements: (27), Under its new import policy, the FDA will also require baby formula companies to provide documentation of factory inspections to ensure their products meet the highest safety standards. infections can be deadly, especially to newborn babies. (90)(91), Liquid formulas werent included in this recall. (103). Regular formula shipments take around two weeks to reach the US, but theyre now expected to arrive within just 72 hours with these special flights. (23). (29), The White House released these measures that the Biden administration plans to follow for an increase in the number of formula products in the market, but without compromising babies safety: (29), Amid the formula shortage, some unscrupulous retailers or individuals bought dozens of formulas from legitimate suppliers but marked them up to several times the actual price for online retail to desperate parents. However, the authorities are still investigating to confirm whether the formula might have contributed to the death of one of these babies. (4), FDA maximum limits in ppb or parts per billion for infant rice cereal: (5). As of press time, Abbott is still working with the FDA on the corrective actions needed at the facility before they can resume production. It could lead to a decrease in IQ and possible antisocial behavior in young children. (47), However, the FDAs published guidance still requires formula manufacturers to meet the minimum requirements for specific nutrients, labeling, and product safety tests. Amid the formula shortage following issues hounding suppliers earlier this year, including the massive Similac recall, many parents continue to face difficulties in finding products for their little ones. (27), Rep. Andy Harris, the Appropriations subcommittee chair, blamed the problem on leadership issues, not on a money or budget problem. (28), Instead of heading for Indianapolis again, this next shipment is expected to land in Pennsylvania for distribution through the Nestle facility in the area. These were produced in Abbott Nutritions Sturgis, Michigan facility. (49), Some American parents who ordered European formulas directly from Europe had their orders seized and destroyed by US customs agents. These can include sepsis (blood infection) or meningitis (inflammation of the membranes protecting the brain and spine). They also want the FDA to address the other heavy metals detected in baby food, such as cadmium and mercury, which arent included in the agencys new proposal. (4), In response to the investigation, the company wrote to Subcommittee Chairman Raja Krishnamoorthi that heavy metal testing is only done for its internal monitoring program under the company policy. Call Abbott Nutrition for more information: Nutricia KetoCal 3:1 tested positive for Cronobacter (a type of bacteria also involved in the massive Similac recall in February 2022) during routine screening by Australian customs. All four cases were hospitalized, with one possible death due to Cronobacter. (24), The Biden administration had previously announced that they will import formulas as one of the measures to help ease the US shortage. (97), Necrotizing enterocolitis (a severe intestinal infection), In 2001, Mead Johnson Nutritionals recalled Enfamil Nutramigen ready-to-use liquid and powder formulas due to incorrect preparation instructions in Spanish. (4). Yet, the actual results are still several times higher than the, content. It might even cause an imbalance in their body that could cause their heart to stop. The recall was issued after four infants from three different states (MN, OH, and TX) fell ill and were hospitalized after reportedly consuming the Similac powdered infant formula mentioned above. (42), An Abbott spokesperson explained that their strong balance sheet let them invest in improving their facilities even if they offered the stock buybacks. (75), After conducting separate investigations, Enfamil and Publix assured customers that it was an isolated incident. You can immediately consult your childs specialist pediatrician, metabolic physician, neurologist, or dietitian before you stop using the formula. ** Human milk oligosaccharides (HMOs) are a group of prebiotics found in human milk, and 2'-FL is the most abundant found in breastmilk. Aside from this measure, the USDA (United States Department of Agriculture) is coordinating with different states to let WIC recipients buy available products (instead of only buying WIC-approved options). But they concluded that it must have happened sometime after the containers were opened. (42), When news of the recall hit, the company allegedly increased dividends to shareholders by over 25%. (47), FDA Commissioner Robert Califf announced on May 16, 2022, that their loosening restrictions on imported infant formula to efficiently and safely improve the local supply. (101), But the FDA doesnt need to approve these formulations before these can be marketed. (8), After a three-week shutdown due to damage from the floods in the area, the Abbott plant in Sturgis, Michigan, has finally reopened again. Two of these baby deaths were among four confirmed, infections that led to the Similac recall in February. They recalled the following products: Pedialyte Electroyle solutions Similac Stage 1 Similac 360 Total Care (27). Unfortunately, they were unable to tolerate the new formulas and suffered from dehydration. However, finding a suitable formula can be a difficult process for these children. The powdered contents settled while the water was on top. Abbott voluntarily recalled another Similac product to the on-going recall: a lot of Similac PM 60/40 with lot #27032K80 (can) or lot # 27032K800 (case). (75), Frydrychs husband tasted it and confirmed that it was flour. Contaminated baby food and infant formula can be dangerous to your childs health. Gentle Nutrition: Modeled after the complete nutrition and gentleness of breastmilk, this formula offers complete nutrition for babies up to 12 months There are so many possible contaminants and harmful ingredients in our food supply. Cheese Ravioli Pasta Pick-Ups were recalled, but not because of, Undeclared egg components (allergens) on the product label. Formula Type. (51), She also recommends keeping the cows milk at 24 oz or less and providing your baby with their formula or a close alternative as soon as possible. About this item . FDA maximum limits in ppb for bottled water: EPA (Environmental Protection Agency) maximum limit in ppb for drinking water (also applies to food): The Subcommittee was alarmed that the companies didnt correct the heavy metal levels in their raw materials and finished products. Over the years, Gerber had issued some baby food recalls. Updating their training, education, and safety procedures applicable for employees and visitors, Updating protocols for cleaning, water, and maintenance procedures, Upgrading the plant, including installation of sanitary, easily cleanable, and nonporous floors, Abbott Nutrition Releases Some On-hold Products Amid Formula Shortage, include Similac, Alimentum, and EleCare powder formulas. The company has informed the FDA of the new setback and announced that production will likely be delayed for a few weeks. A review of the firms internal records also indicate environmental contamination with Cronobacter sakazakii and the firms destruction of product due to the presence of Cronobacter. (24). (31), Customs data from ocean cargo shipments showed that the company shipped as much as 2.4+ million cans from January to May 2022 (excluding air cargo). (34). (95), These bottles had a missing special layer that keeps the air out. (94), There werent any serious health problems reported concerning this recall. She added that there should be restrictions imposed on companies receiving federal funding or having federal programs as their largest customers, such as the WIC in Abbotts case. (2), It contained much higher iron, potassium, and sodium content than the maximum limits. (89), The affected products were produced at a plant in Sturgis, Michigan. The case is still under investigation, with authorities trying to determine the cause of the infants Cronobacter sakazakii infection. (75), In response, Enfamil assured customers that theyre confident about the safety of their products because of their long history of quality. (25), Childrens Wisconsin also had treated an undisclosed number of children, according to Jennifer Crouse, the Clinical Nutrition Manager. 03518QU (manufacturing date March 2019; and expiration date March 2022) (73), Parents Choice Advantage Infant Formula Recall. On December 11, 2022, formula manufacturer ByHeart voluntarily recalled five batches of its Whole Nutrition Infant Formula due to a concern of potential contamination with Cronobacter sakazakii, a bacteria sometimes found in dry foods that can cause life-threatening infections and meningitis. this list to find the formula on your WIC benefits. Theyre no longer sourcing material from the affected supplier as of press time. According to director Brian Deese of the White House National Economic Council, the military cargo plane (from the Air Force cargo) carried 15% of the USs demand for specialty medical-grade baby formula. (63), Federal safety inspectors released their findings after conducting an investigation at Abbotts manufacturing plant in Sturgis, Michigan. (85), Police arrested Jennifer LaPlante over the incident. According to Bellinger, her husband prepared several formula bottles and put them in the fridge before sleeping. (13). The company explained that even minor differences in the packaging can hide a safety or tampering issue.
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