Get email updates delivered to your inbox. (9), FDA deputy commissioner Frank Yiannas of the Office of Food Policy and Response announces his resignation, effective February 24, after being criticized in an independent review for the way his office handled the formula shortage crisis. These improvements include the following: (62), Abbott Nutrition announced that theyre fulfilling the FDAs request to release some metabolic nutrition and specialty formulas put on hold in February following the Similac recall. The U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC) and state and local partners are investigating consumer complaints and/or reports, received from 9/20/2021 to 1/11/2022, of infant illness related to products from Abbott Nutritions Sturgis, MI, facility. Babies R Us Gentle Infant Formula (Perrigo)* (102)(103), Repeated consumption of the incorrectly prepared formula for several days may lead to the following: (102)(103), Babies living in hot climates or already ill (with other medical conditions) may have a greater risk of experiencing potentially fatal complications. Nestl Health Science - Alfamino Infant - Infant Formula 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. Hominex-2 Acknowledging this, Abbott Laboratories CEO Robert Ford apologized to the public and detailed the serious steps the company is taking to help solve the problem. Neocate is Halal and Kosher, while Alfamino is not. However, founder and CEO Leila Strickland says that it can take years before the product is released. (28), The next formula shipment is for 114 pallets of Gerber Good Start Extensive HA formula, again through Operation Fly Formula. In February 2022, Similac recalled several powdered formulas for possible contamination with bacteria, specifically Cronobacter sakazakii and Salmonella. (41), Abbott needs to comply with a legally binding consent decree signed off by a federal judge between the company and the FDA. Abbott EleCare Infant Formula Unflavoured , like breast milk, can be your babys primary source of nutrition. Contains 2'FL and LNnT , to nurture infants . Mead Johnson (Enfamils manufacturer) sent her a shipping box so they could test the product. (16), The formulas will arrive in Fort Worth, Texas starting on June 24. (37), Aside from getting resistance in Congress, the bill is also expected to encounter strong opposition in Senate after Republican senators questioned why the FDA wasnt held accountable for the possible lapses that led to the infant deaths linked to Abbotts formulas. Information Regarding Medically Necessary Specialty Infant Formulas The White House believes that if manufacturers focus on simplifying product offerings, then they might increase production. https://www.abbott.com/corpnewsroom/nutrition-health-and-wellness/abbott-update-on-powder-formula-recall.html, Metabolic Healthcare Professional/Customer letter from April 29, 2022, Healthcare Professional letter from May 3, 2022, Request form for Metabolic formulas and Similac PM 60/40, Abbott enters into consent decree with FDA, Healthcare Provider Update from May 18, 2022, May 24th EleCare and EleCare Jr. FDA collaborates with CDC, which has developed a detailed questionnaire specifically for Cronobacter infections that is often used by state health departments in instances of Cronobacter sakazakii infection. She got an Enfamil AR formula from a Walmart location in Arizona. (39), The FDA asked lawmakers for a budget increase from last years $2.1 billion to $8.4 billion so they can use it to improve food safety and nutrition. Nestle (NESN.S) has recalled a batch of its Alfamino amino acid specialist infant formula in Germany, saying a number of the products have a substantially increased dose of minerals that could . (89), Police arrested Jennifer LaPlante over the incident. Academy of Nutrition and Dietetics. CVS Health Added Rice Infant Formula (not for use in infants with rice allergy) (Perrigo)* (51), 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. Health care professionals may contact manufacturers for information or assistance to obtain products. Good Start Gentle Pro (Gerber) Two of these baby deaths were among four confirmed Cronobacter sakazakii infections that led to the Similac recall in February. Talk to your healthcare professional to see if Extensive HA and Alfamino formulas are right for your child. This location was chosen because a Nestle distribution center is located just a mile away. No. Only one batch (lot code C26EVFV with a use by date of February 26, 2021) was affected. (109), The FDA will use a tool created during the COVID-19 pandemic to track supply chain shortages. In addition, the FDA is asking that health care providers report any adverse event related to a shortage of medically necessary infant formula products. Nutramigen (Reckitt Mead Johnson) Infant formula, like breast milk, can be your babys primary source of nutrition. Substitutions. Yes. (Read our Similac recall article for the list of affected lots). It is important for parents and caregivers to understand that any products released on a case-by-case basis at this time were made at Abbott Nutritions Sturgis, MI, facility, and that the processes, procedures, and conditions that the FDA observed during its inspection of the Sturgis MI production facility from January 31 March 18, 2022, raise concerns that powdered infant formula produced at this facility prior to the FDAs inspection carry a risk of contamination. The infant formula shortage 2022: Subsitutions for parents That's why it's always important to watch out for formula recalls and safety issue warnings or news. The Salmonella Newport illness previously included in this investigation of complaints and illnesses has been removed. (89), Gerber didnt issue a recall because it was considered an isolated incident. Similar 360 Total Care Sensitive (Abbott) Abbott Similac Alimentum Infant Formula with Iron Deaths: 2 States: 3 (Minnesota, Ohio, Texas) Recall: Yes Investigation status: Closed View Larger Recalled Powdered Infant Formula FDA has published a full list of recalled powdered infant formula. (108), Some cases against Abbott were dismissed by U.S. District Judge Matthew Kennelly at a court in Chicago. The products from Abbott Nutritions Sturgis, Michigan facility have been distributed across the US and are likely to have been exported to other countries, the recall advisory warned. The product also failed to meet the FDAs labeling requirements because it doesnt show a UPC (Universal Product Code) and a manufacturing lot code. Although they havent confirmed how many units have been recalled, the formula recalls include Similac, Alimentum, and EleCare (first recall), and Similac PM 60/40 (second recall). The table below has links to assist with locating infant formula for families. The company is now the US largest formula supplier after Similac was hounded with issues in 2022. They put their money to help the shareholders instead of improving the plant or making productive investments. Many of them believed that the FDA doesnt need more staff. The affected products might have metal parts up to 2.7 mm in size. (91), Neither Mead Johnson nor the FDA issued a product recall over the issue. (89), In September 2016, the FDA recalled this formula by Graceleigh, Inc. for failing to meet infant formula regulations. (73), The company also reportedly admitted to the FDA that they arent testing for the presence of, a potentially dangerous and deadly bacteria, especially for babies. After further investigation, the FDA has determined that there is not enough information to definitively link this illness to powdered infant formula. ALFAMINO INFANT formula is a hypoallergenic, amino acid-based formula for infants 0-12 months of age. Even though Cadden explained that she didnt create the problem, she has received threats from people who said shes killing American babies and working for Satan. (58), US President Joe Biden met with retailers and baby formula manufacturers, particularly Gerber, Reckitt, Walmart, and Target, to discuss measures to help address the shortage while ensuring that formulas reach store stores safely. Cronobacter infections can be deadly, especially to newborn babies. In the meantime, the FDA is continuing to work diligently to ensure the safe resumption of production of infant formula at Abbott Nutritions Sturgis, Michigan facility. The products were sent to the facility for standard quality control checks before distribution to pharmacies, hospitals, and doctors offices. Comforts Soy Infant Formula (Perrigo)* Similac Neosure Ready To Feed (Abbott)*** The .gov means its official.Federal government websites often end in .gov or .mil. Symptoms caused by Salmonella usually include fever, diarrhoea and abdominal cramps. ALFAMINO JUNIOR | Nestl Medical Hub for Healthcare Professionals To date, no outbreaks of Cronobacter have been detected using WGS. Abbott Similac Organic (72), These formulas were recalled for failure to meet FDA requirements (U.S. Food and Drug Administration) for pre-market notifications. This nutritionally complete formula has a unique fat blend containing 43% medium chain triglycerides (MCT) to . ZURICH (Reuters) - Nestle has recalled a batch of its Alfamino amino acid specialist infant formula in Germany, saying a number of the products have a substantially increased dose of minerals that could make children sick. (47), While the nationwide out-of-stock rate was around 40% in April 2022, it soared to 50% in the following states: (48), Sometime in May, Nevada announced that its also experiencing a decrease of at least 50% of the states baby formula supply. The FDA is now investigating the infant death which reportedly happened in January. ** Formulas in this standard formula/intact and/or partially hydrolyzed cows milk protein category are safe to substitute for each other in case of national shortages. More information will be provided as it becomes available. NIDO 1+ (Nestl) All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. Enfamil has had some formula recalls (plus some tampering issues) in the previous years. RECALLED FORMULA. Abbott Similac EleCare HMO (96)(97), 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. The recall worsened the formula shortage that was already affecting the US since 2021. Similac Pro Sensitive Ready To Feed (Abbott) FDA is continuing to investigate and will update this advisory should additional consumer safety information become available. So, any changes to their formula have to be carefully monitored for tolerance or they could end up getting sick. ALFAMINO INFANT | Nestl Medical Hub for Healthcare Professionals (63), The office of House Appropriations Committee Chair Rep. Rosa DeLauro received a 34-page report from a whistleblower who used to work at the Abbott Nutrition facility that produced the recalled Similac formulas in February 2022. Instead, you should take it to the store for a refund and exchange or call the company at 1-800-986-8540 to help you. (2), This voluntary recall affects approximately 145,000 cans manufactured in two batches. This hypoallergenic, amino acid based recipe delivers complete nutrition to infants from 0-12 months. Families have also noted difficulties finding other powder formulas that are typically available on store shelves including formula for premature infants and hypoallergenic formulas. Once you find some formula, switch back immediately. They added that the former employee made a false report and submitted it to multiple authorities after his dismissal. We are also partnering with the United State Department of Agricultures Food and Nutrition Service (FNS) to monitor the impact of the recall on The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Program. As Abbott Nutrition was initiating its recall, FDA intensified this outreach to infant formula manufacturers to inquire about their capacity and potential impacts given this developing situation. (33). the code on the container contains K8, SH or Z2; and. Reported Deaths: 2* Kendamil Goat Stage 1 (Kendal Nutricare, United Kingdom) Please consult your healthcare team with any questions about the appropriate nutrition for your child. Learn More. Tyrex-1 (39). (85), Enfamil didnt recall the formula. Burts Bees Baby Sensitive (Perrigo) Peptamen Jr Powder (Nestl) Similac Special Care Ready To Feed (Abbott)***. (98), This contamination was attributed to a manufacturing problem. We use cookies to optimize and personalize your experience, provide relevant content and analyze online traffic. Elecare Infant (Abbott) Studies show that most meet FDA-required nutrient levels. They were sold in retail stores in these areas: (2), If you have any of these affected Enfamil ProSobee formulas, immediately stop using them. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case. It has a unique fat blend containing medium chain triglycerides (MCT) to . All trademarks are owned by Socit des Produits Nestl S.A., Vevey, Switerland. Enfamil Enfagrow Premium Toddler Transitions Gentlease (Reckitt Mead Johnson) (2). Also, the company insists that its products arent the source of the infections based on internal investigations. (59), To avoid hoarding, retailers like CVS, Walmart, and Target have put a cap on the quantity that consumers can buy. Gerber Extensive HA (Gerber) Up & Up Sensitivity Infant Formula (Perrigo)* Alfamino Junior formula is a nutritionally complete amino-acid based formula for children 1+ years of age, for the dietary management of children with cow's milk protein allergy, multiple food allergies and malabsorptive conditions. USDA does not endorse any goods, services, or enterprises. It looked like cans were available to purchase on Amazon then (and we ordered a couple) but it seems like no place has them now since the Similac formula recall stuff started. FDA is continuing to investigate and will update this advisory should additional consumer safety information become available. Nan Expert Pro Sensitive Pro (Nestle, Germany) The second flight is expected to arrive in the coming days. Considering the deaths and hospitalizations of several infants linked to the possible contamination, something must be done to correct this serious safety concern. (35), After the Similac recall, Enfamil now feeds around 211,000 more babies than it had before the formula shortage began. The FDA recall advisory announced some positive results from test samples at the facility: Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. Heres Abbotts statement regarding this massive recall: Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. (105), But the FDA doesnt need to approve these formulations before these can be marketed. The recall impacts Alimentum, EleCare, and Human Milk Fortifier for markets outside the U.S. No other Abbott Nutrition products distributed outside of the U.S. are affected by this recall. These were produced in Abbott Nutritions Sturgis, Michigan facility. She warns that cows milk should never be considered even as a temporary substitute for babies with special health needs or those using specialty formulas for allergies. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport. (3). The formula contains free amino acids and not intact protein which helps minimize the chance of an allergic reaction. The powder is formulated for children with cow's milk protein allergy, eosinophilic GI disorders, multiple food allergies and malabsorptive conditions. Check for local resources. , which could be the best organic options for your baby: Enfamil ProSobee Simply Plant-Based Infant Formula, Similac and Pedialyte Ready-to-Feed Liquid Products (2022), Similac PM 60/40 (second Similac recall 2022), Kirkland Signature Brand by Costco, Non-GMO Formula For Babies Sensitive To Lactose formula recall Canada (2019), Similac TummiCare One formula recall Philippines (2019), Parents Choice Advantage infant formula recall, Bebe Mandorle Stage 2 (Bio) formula recall (2018), Dumex Mamil Gold (Step 1) infant milk formula recall Singapore (2018), Lactalis Nutrition Sant (LNS) formula recall (2017), Sammys Milk Baby Food formula recall (2016), Similac powdered infant formula recall (2010), Similac Special Care Ready-to-Feed Premature Infant Formula with Iron recall (2007), Similac Liquid Ready-To-Drink Formulas Similac Advance With Iron and Similac Alimentum recall (2006), Enfamil formula recall Gentlease (2006), Similac Advance with Iron Formula Powder recall (2005), Mead Johnson EnfaCare LIPIL formula recall (2003), Milupa Aptamil 1 Pronutra store recall In Slovenia (2018), Enfamil Formulas CVS store recall (2018), Enfamil AR possible product tampering (2018), Gerber Good Start Soy Formula possible product tampering (2017), Gerber Good Start SootheProTM Powdered Infant Formula, On March 17, 2023, Perrigo Company plc recalled some lots of Gerber Good Start SootheProTM Powdered Infant Formula due to the possible presence of, 1-800-777-7690, 24/7 (any time of the week or day), On February 20, 2023, Reckitt voluntarily recalled two batches of Enfamil ProSobee Simply Plant-Based Infant Formula (12.9 oz) due to possible cross-contamination with, Meningitis (inflammation of the brains lining), Jaundice (yellowing whites of the eyes and skin), UPC (Universal Product Code): 300871214415, ByHeart Whole Nutrition Infant Formula Recall, On December 11, 2022, baby nutrition company, ByHeart voluntarily recalled their Whole Nutrition Infant Formula, (five batches) due to possible cross-contamination with, Abbott Nutrition Recalls Ready-to-Feed Liquid Products. To date, this case-by-case release has provided life-sustaining products to 2,958 infants and individuals in need, and approximately 500,000 containers of additional product remain accessible to those in need. Kendamil Organic Stage 1 (Kendal Nutricare, United Kingdom) Similac Sensitive (Abbott) The next best thing to breast feeding is Alfamino Infant Formula. Abbott Similac Pro-Total Comfort Infant Formula with Iron Enfamil Newborn Infant (Reckitt Mead Johnson) Gerber Good Start Soothe Pro (HMO) Infant Formula - 30.6 oz can, single pack: $36.48. Products made at the Sturgis facility can be found across the United States and were likely exported to other countries/locations as well. To report an illness or adverse event, you can. 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. (51), Also, the US levies heavy tariffs on imported infant formula as high as 17.5%. Abbott Nutrition: 1-800-881-0876 (Alimentum, EleCare, and metabolic products), Mead Johnson/Reckitt: 1-812-429-6399 (Nutramigen, Puramino, and metabolic products), Nutricia: 1-800-365-7354 (Neocate and metabolic products), Gerber Products Company: 1-800-284-9488 (Gerber Good Start Extensive HA Infant Formula), Nestl Health Science: 1-800-422-2752 (Alfamino products). But many recalls also involved contaminants or manufacturing defects. CVS Health Soy Infant Formula (Perrigo)* Homemade formulas may not have the rightlevels of certain nutrients, which could cause nutrient imbalances that may be harmful. Abbott Similac EleCare Abbott EleCare Similac Gold (79)(80), At first, she thought that the name brand had changed the formulation. However, the FDA recall advisory didnt indicate the values of their test results. Abbott Nutrition explained that only one lot of this product was recalled in February. The shipments are but a small fraction of the US formula production. Healthcare professionals may recommend an amino-acid based formula such as Alfamino , for the management of food allergies (including the most common one, cow's milk protein allergy) or for other medical conditions. Background: The FDA announced on February 17, 2022 (FDA advisory), that they are investigating an outbreak of Cronobacter sakazakiiandSalmonellaNewport infections in 4 infants across 3 states (Texas, Ohio, Minnesota) that have been linked to consumption of Similac, Alimentum, or EleCare powdered formulas produced in Abbott Nutritions Sturgis, Michigan facility. Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula To increase the supply of infant formula, the FDA is: If you have questions about this notice or for general information about infant formula, contact FDAs Center for Food Safety and Applied Nutritions Food & Cosmetic Information Center. Up & Up Advantage Infant Formula (Perrigo)* Illness Onset Date Range: 9/6/2021 1/4/2022 In total, this investigation includes four reports of Cronobacter sakazakii infections in infants (three from FDA complaints and one from a CDC case finding) and one complaint of a Salmonella Newport infection in an infant. (36), The bill was passed in the House with a large bipartisan majority vote. Alfamino Infant formula An amino acid-based infant formula designed for multiple food allergies, or if CMPA symptoms persist after trying an extensively hydrolyzed formula. Similar Pro Advance Ready To Feed (Abbott) Meijer Infant Formula (Perrigo)* ByHeart Whole Nutrition Infant Formula (ByHeart) Update: 2/24/23. Abbott Similac Total Comfort Infant Formula with Iron They also offered shareholders a stock buyback program thats worth $5 billion. Many of these European formulas arent approved by the FDA, but many parents still prefer them over US brands. Babies R Us Complete Comfort Infant Formula (Perrigo)* 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. (17), Severe thunderstorms hit Michigan, resulting in power outages and flood damage, including areas of the Abbott plant. Infant / Pediatric Formula Information Pertaining to Abbott Recall of The whistleblower alleged that Abbott Nutrition: (64)(65), 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. Extensive HA and Alfamino formulas are WIC, Medicaid and SNAP eligible; Insurance Support. Similac Advance (Abbott) (38), It will include a $76 million increase to be used for the following: (38), Califf told lawmakers that the FDA needs these major improvements, not because of bad people but because the agency needs the right resources and consistent leadership. Although CORE is no longer investigating this incident, the FDA established an Incident Management Group (IMG) on April 1, 2022, to continue to work on supply chain and food safety issues. At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the only type and lots of this specialty formula being recalled. Earths Best Organic Soy (Earths Best) (2), For questions, assistance in verifying products, or other questions, you can contact Reckitt through the following channels: (2), Thankfully, no illnesses, injuries, or adverse reactions relating to this ProSobee recall have been reported. If your child is under 1 year of age (or corrected age, if your child was born prematurely), do not provide non-dairy cows milk alternatives such as almond, soy, coconut, or oat milks. If you are not able to find formula from the manufacturers, email emergency.operations@fda.hhs.gov to report the problem. Members Mark Infant Formula (Perrigo)* Well Beginnings Sensitivity Infant Formula (Perrigo)*, Aptamil Gold Plus Stage 1 (Nutricia, New Zealand) (101), 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. Before sharing sensitive information, make sure you're on a federal government site. As of press time, Abbott is still working with the FDA on the corrective actions needed at the facility before they can resume production. (42), It was filed at the US District Court for the Western District of Michigan, with Abbott needing to follow these steps: (42)(43), The consent decree also requires Abbott to immediately stop production and notify the FDA of any kind of contamination experienced at the plant. In these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection. Abbott Similac Alimentum with 2'-FL HMO Meijer Gentle Infant Formula (Perrigo)* (2), The recall advisory explains that Cronobacter sakazakii can lead to the following potentially life-threatening conditions: (2), Symptoms of sepsis and meningitis can include: (2), Affected products have the following information printed on the bottom: (2), These affected Enfamil ProSobee formulas were manufactured between August 2022 and September 2022. Later, she noticed that the powder settled to the bottom of the bottles. Products are included in the recall if they have all three items below: In addition to products described above, Abbott Nutrition has recalled Similac PM 60/40 with a lot code 27032K80 (can) / 27032K800 (case). This nutritionally complete formula provides essential nutrients your little one needs to grow. Check any powdered infant formula you have at home to see if it has been recalled. Nestle : recalls batch of Alfamino infant formula in Germany Nestle recalls batch of Alfamino infant formula in Germany - Yahoo Finance This can give them more options than WIC-approved brands that could be unavailable due to a recall or shortage.