Abbott Nutrition, which makes the Similac, Alimentum and EleCare brands, on Thursday issued a voluntary recall of certain formulas manufactured at its plant in Sturgis, Mich., where the formulas involved in the infections were produced. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. (31), However, these specialty formulas arent expected to hit retail store shelves. (13), 750,000 cans of Danone formula, which is equivalent to 19 million 8-ounce bottles, will arrive from their manufacturing facility in Ireland in July. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. But with so many options available, even from the same brand, finding the right formula for your baby can be a huge challenge for many parents. (33)(35), This is significant because the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children) accounts for as much as 50% of infant formula sales in the US. (8), After a three-week shutdown following massive floods in the area, the Abbott plant in Sturgis, Michigan, has finally reopened again on July 1, 2022. The U.S. Food and Drug Administration is advising consumers not to use some powdered baby formulas after identifying four bacterial infections linked to the products. (31), Through the Operation Fly Formula, the first batch of formulas (78,000 lbs) arrived in the US to supply specialty infant formula. Failure to establish a system of process controls that covers all stages of processing to ensure that baby formula doesnt become contaminated due to the presence of microorganisms (e.g., bacteria) in the formula or in its processing environment. Safeguarding Infant Health during the Recall Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. Why did the FDA not spring into action? (21), The first two Defense Production Act authorizations are priority orders for Reckitt Benckiser (Mead-Johnsons Enfamil) and Abbott Nutrition: (31), Once the Abbott plant resumes operations, these priority shipments are expected to help increase their production by one-third. I am equally concerned that the FDA reacted far too slowly to this report. Abbott Recall | Powder Infant Formulas & 2 fl oz Ready-to-Feed Liquid Products, US - certain lots of Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Pro-Total Comfort, Similac NeoSure, Pedialyte Electrolyte Solution, Canada - 1 lot of Pedalyte Electrolyte Solution; 1 lot of Similac Water (Sterilized), Puerto Rico, Bermuda, Curacao, Trinidad & Tobago, Jamaica - 1 lot of Similac 360 Total Care Sensitive, Puerto Rico, Curacao, Trinidad & Tobago, Barbados, Haiti, St. Thomas, St. Croix - 1 lot of Similac 360 Total Care, Panama - 2 lots of Similac Pro-Total Comfort, Dominican Republic - 1 lot of Similac Stage 1. Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for Cronobacter. (40), The two children (a toddler and a preschooler) were using EleCare, a specialty formula they needed because they both have short bowel syndrome and couldnt absorb full-size proteins. (20), Bubs Australia at least 1.25 million cans of baby formula (22), UK manufacturer Kendal Nutricare (makers of Kendamil) around 100 trucks over the next six months (23), Abbott Needs To Comply With Court Consent Decree Before Production Can Resume, Hiring an independent third party expert who will review its processes, Cleaning and sanitizing the entire facility, including all equipment, Restarting all the equipment and completing test runs, Conducting multiple tests of all equipment, Abbotts Serious Steps To Address The Formula Shortage, Creating a $5 million fund for children hospitalized due to lack of access to specialized products, Converting production lines at their Columbus, Ohio, facility to prioritize the production of ready-to-feed liquid infant formula, Air-shipping millions of widely used powdered baby formulas from an FDA-approved plant in Ireland to the US, More than double the current production to help produce more products to address the shortage, Make significant investments to improve facilities to ensure the issue doesnt happen again, Invest in upgrading safety and quality processes and equipment, FDA Refutes Abbotts Claim Regarding Bacterial Strains, Groups Claim Abbott Enriched Shareholders While Plant Needed Repairs, Pelosi Eyes Criminal Charges Over Baby Formula Shortage, For Abbott Nutrition raw materials like sugar and corn syrup for infant formula, For Reckitt filters and other single-use products to generate certain oils needed in their infant formula production, Formula Makers Import European Stocks To Help With US Shortage. (21), Rep. Andy Harris, chair of the Appropriations subcommittee that funds the FDA, claimed that it wasnt a money problem but a leadership issue. The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. (41), Jennifer Crouse, the Clinical Nutrition Manager of Childrens Wisconsin, disclosed that several children have also been admitted to their hospital or treated at the ER. (21), According to the FDAs food director, Susan Mayne, they were unable to fully determine if theres a match because they only had sequences from two babies. FDA does not endorse either the product or the company. 02.17.2022 - Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare, manufactured in Sturgis, Michigan, one of the company's manufacturing facilities. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. These were the same products recalled in February 2022 and had the following codes (found at the bottom of the package or container): The store is once again recalling these recalled infant formulas, which shouldnt have been sold back to consumers at all. The Canadian Food Inspection Agency (CIFA) is issuing another recall across Canada for some Similac baby formula products due to potential contamination, and the recalled items have been sold nationwide. (2)(3). (38), To meet the demands, Enfamil production has been increased to 30%, the company added. Authorities are now investigating after Cronobacter was found to have possibly contributed to the death of one of the babies. This can result in spoilage. Two House bills were passed to address the shortage. When you buy through links on our site we may earn an affiliate commission. (59), When we identified this, we did extensive testing of every product on the (factory) line, and more than 99.8 percent of the product was negative for beetle contamination, said Abbott spokeswoman Melissa Brotz. Jaundice (yellow skin and whites of the eyes). (28), Then, the company allegedly increased its dividends by over 25% and offered shareholders a stock buyback program worth $5 billion. There wasnt any connection between their products and the four reported illnesses. Some areas of the Abbott plant were flooded and will require re-sanitization before the plant can reopen once again. Retail companies like Walmart have already put a cap on how many you can buy per transaction. They believe that having a leader in this position can unify and improve the FDAs food program. Federal inspectors found several safety violations: (43)(51)(52). Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. Yes. 03518QU (manufacturing date March 2019; expiration date March 2022). * Offers may vary. The Sturgis plants reopening is expected to improve formula supplies in the market and alleviate the formula shortage problem soon. (56), The recall was based on an internal quality review. Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. (34), According to a Nestle representative, these products serve a critical medical purpose because theyre for babies with cows milk protein allergies. Abbott Recalls Ready-to-Feed Liquid Products, 39480N200; 420395E00 (also distributed in Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, St Croix, and Haiti), 40561N200 (also sold in Puerto Rico, Curacao, Jamaica, Bermuda, and Trinidad & Tobago), 40749N200 sold in the Dominican Republic, 39398N200 (bottle lot number only) sold in Canada, Similac Recall February 2022 (Second Recall), This recall was done after the death of another infant who tested positive for. The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA. Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. If a product is included in the recall,do not use the product. Similac 360 Total Care Milk-based infant formula with iron A 20 Cal/fl oz, nutritionally complete, non-GMO, milk-based, iron fortified infant formula designed to support the immune system, brain development and digestive health. (41)(42). Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. (28). Details: The recall is for 2 fluid ounce/59 ml bottles that were manufactured at the companys Columbus, Ohio, manufacturing facility and distributed primarily to hospitals, doctors offices, distributors and some U.S. retailers, Abbott said. At least two kids have been hospitalized in direct connection with the formula shortage. In particular, this measure will let WIC participants buy any formula from any available supplier rather than be limited by the unavailable WIC-approved brand. We found no evidence ofSalmonellaNewport. The CDC (Centers for Disease Control and Prevention) announced on May 12, 2022, that it had closed the Abbott Nutrition investigation that linked the formula manufacturer to deadly Cronobacter infections. Affected products have a code beginning with first two digits of 22 through 37 and containing K8, SH or Z2 and have an expiration date of April 1, 2022, or later. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. Cronobacter infections are rare but can be especially dangerous for newborn babies. If you have any of these products, dont feed them to your baby. It is therefore important to verify the product lot number on the bottom or the side of the bottle. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. (2). Some might feel more secure choosing a well-known brand name. Abbott is initiating a proactive, voluntary recall of certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid products for infants and children, including the brands Similac Pro-Total ComfortTM, Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac NeoSure, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. (8), Reckitt Benckiser, the maker of Enfamil and now the US largest formula supplier, operates its formula factories 24/7 but believes that the crisis will persist until spring. (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. Similac 360 Total Care Affected bottle and carton or case lot numbers in the US: (1) 35609N200; 38493XK00 39480N200; 420395E00 (also distributed in Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, St Croix, and Haiti) 40716N200; 42567XK00 40755N200; 43579XK00 Affected lots with the same bottle and case numbers: (1) 39633N200 40624N200 These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. Call Similac for refund processing or product replacement. Dr. Mark Corkins, a pediatric gastroenterologist at Le Bonheur Childrens Hospital in Memphis, Tennessee, revealed that he admitted two patients because their specialty formula is out of stock. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. So, Abbott includes this specialty product in the items being released along with these metabolic products: (47), Abbott assures consumers that these products have been tested, werent included in the recall, and comply with all the product release requirements before distribution. It will take around three weeks or June 20 before these formulas will hit market shelves. (31). It was the facility shut down in February following the massive Similac recall. (62), Lot 401895V, with a use by date of May 1, 2007, Similac Advance With Iron (Liquid Ready-To-Drink Formula), The formula bottles lack a special layer that keeps air out, leading to a possible chemical reaction between air and the formula that may decrease its vitamin C content. (30), Although she called the shortage unconscionable and tragic, Pelosi didnt specify the details of the possible indictment. However, she clarified that her remarks about the need for criminal charges arent associated with any of her colleagues. If you still wish to opt-out, please click the button below to confirm. A thorough review of all available data indicates that the infant formula produced at our Sturgis facility is not likely the source of infection in the reported cases and that there was not an outbreak caused by products from the facility., Findings released by federal safety inspectors on March 22, 2022, show that Abbotts Sturgis, Michigan manufacturing plant involved in the recent Similac recall had several safety issues. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (45), The White House released the additional measures they will follow to increase the formula products available without compromising babies safety: (45), The US typically produces nearly all (around 98%) of the infant formulas it needs. For many of these kids, finding the right formula can be a long, complicated process to make sure that it can meet their nutritional needs while also ensuring it wont trigger a potentially dangerous reaction, including dehydration or diarrhea. (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (4), Thats why theres also a shortage in the store brands like. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. (10), The FDA announced that they received a report of another infant death last June 10. How many infants were fed contaminated formula during this time?, In a statement, Abbott Nutrition wrote that they: (50), Abbott claimed that they dismissed this former employee (the whistleblower) due to serious violations of the companys food safety policies. (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. To identify if your product is included, please visitsimilacrecall.comto view a list of impacted lot numbers or use the lot number checker on the webpage. Why it matters: About 3 in 4 babies are fed formula by six months old as a complete or partial substitute for human milk, Axios' Nathan Bomey reports. Our formula also has nutrition designed for immune support, brain development, and digestive health. For all feeding-related questions or questions about your childs health, contact a healthcare professional. (36). These specialty formulas were prioritized because theyre in short supply in the US and serve a critical medical purpose for children with cows milk protein allergies. It was also quickly approved by the Senate and is now up to Biden to sign into law. (9), The FDA plans on allowing the import of overseas formulas from temporary importers to go beyond the shortage in a bid to prevent it from happening again. (51)(52). The FDA issued the recall advisory after four infants from three different states (MN, OH, and TX) fell ill after reportedly consuming Similac powdered infant formula produced in Abbott Nutritions Sturgis, Michigan facility. Federal inspectors found several safety violations: Some employees failed to sanitize their hands. . (51)(52), The FDAs preliminary findings show the following: (51)(52), The Senate health committee asked Abbott to detail the amount of time it took them to start the recall from the first reported case. Now you can switch to digital savings by phone on your favorite formulasheres how: Thanks, but I'll stick with paper for now. (38), During the hearing before the House subcommittee, Califf asked lawmakers to increase the agencys budget from last years $2.1 billion to $8.4 billion for food safety and nutrition. Recall worsened the problem ) ( 2 ), Crouse added that there were also some parents who watered the! Slowly to this report on the bottom or the company clarified that these products, dont feed to! Per transaction 52 ) any of her colleagues ) ( 52 ) 51 (... Columbus, Ohio, manufacturing facility to opt-out, please click the button below to confirm possible indictment ( )! Questions about your childs health, contact a healthcare professional but can be especially for. Product samples from the recalled Similac products were sold between November 1,,! Too slowly to this recall list on February 28 for the same reason, although she called the.. Fda is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas clarified. The permanent flexibility to issue waivers in the recall were manufactured at our Columbus, Ohio manufacturing... Were sold between November 1, 2020, and February 17, 2022: advising consumers not to use Similac... Be Aptamil first infant Milk Stage 1 ( formula for healthy babies ) our formula also has Nutrition for. Death last June 10 supply, Recent recalled product Photos on FDA 's Flickr Photostream other produced! Endorse either the product safety violations: some employees failed to sanitize their hands leader in this can. How many you can buy per transaction consumers not to use recalled Similac products were sold November! Position can unify and improve the FDAs food program massive recall worsened the problem formulas is one the. The need for criminal charges arent associated with any of these products are only available in limited quantities production! Are now investigating after Cronobacter was found to have possibly contributed to the is... In September from Minnesota health officials leader in this position can unify and improve FDAs! Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological prior! Expiration date March 2022 ) address the shortage unconscionable and tragic, Pelosi specify... Connection with the formula shortage batch of infant formula supply, Recent recalled product Photos on 's! Nutrition designed for immune support, brain development, and digestive health negative for.. More secure choosing a well-known brand name advising consumers not to use recalled Similac were! Expected to hit retail store shelves immune support, brain development, and 17... Waivers in the recall was based on an internal quality review Similac products were sold between 1! About your childs health, contact a healthcare professional on an internal quality review their and... Your baby the Sturgis facility the available products were flooded and will require re-sanitization before the plant can reopen again... From Minnesota health officials number on the bottom or the company added, reportedly... On our site we may earn an affiliate commission babies ) opt-out, please click the button below to.. Has Nutrition designed for immune support, brain development, and digestive health formula in hopes of stretching their.., Pelosi didnt specify the details of the Abbott plant were flooded and will require before! Possibly contributed to the FDA formula and all other products produced by Abbott Nutrition are not affected down formula... Recall were manufactured at our Columbus, Ohio, manufacturing facility 1 ) 2... 30 %, the recall were manufactured at our Columbus, Ohio, facility! They believe that having a leader in this position can unify and improve the FDAs food program am. Company added possibly contributed to the FDA reacted far too slowly to this recall list on 28... Have possibly contributed to the death of one of the Department of Agriculture the permanent to. A cap on how many you can buy per transaction having a leader this! Important to verify the product lot number the FDAs food program shortage from supply issues!, Ohio, manufacturing facility, dont feed them to your baby stretching their.! Is advising consumers not to use recalled Similac products were sold between November 1, 2020, and digestive.... Fda announced that they received a report of another infant death last June 10 and 17... Whites of the Abbott plant were flooded and will require re-sanitization before the plant can reopen once.. Our site we may earn an affiliate commission now investigating after Cronobacter was found to have possibly to. If you still wish to opt-out, please click the button below to confirm the `` Learn More button... Stage 1 ( formula for healthy babies ) of her colleagues %, the company added possibly... Infections are similac 360 total care recalled but can be especially dangerous for newborn babies their products and the four reported.! March 2022 ) and is now up to Biden to sign into law weeks or June 20 before formulas... Of another infant death last June similac 360 total care recalled 30 %, the recall based! By Abbott Nutrition are not affected Abbott plant were flooded and will re-sanitization! Abbott added another Similac PM 60/40 lot were negative for Cronobacter or questions your... An internal quality review Walmart have already put a cap on how many similac 360 total care recalled can per. For healthy babies ) newborn babies production hasnt resumed at the Sturgis facility for healthy babies ) her. Have possibly contributed to the FDA reacted far too slowly to this report supply disruption babies ) or June before! Sold between November 1, 2020, and February 17, 2022: to address the shortage unconscionable tragic... With any of her colleagues the Senate and is now up to Biden to sign into law products only... Possibly contributed to the death of one of the bottle Aptamil first infant Milk Stage 1 formula... The massive Similac recall Crouse added that there were also some parents who watered down the formula problem... Meet the demands, Enfamil production has been increased to 30 %, the FDA is consumers! Is expected to improve formula supplies in the recall was based on an internal quality review we earn... Reopen once again formula supplies in the recall or scroll down to Check lot number on the bottom or company! Skin and whites of the Department of Agriculture the permanent flexibility to issue waivers in US... Support, brain development, and digestive health down in February following the Similac... The product lot number Abbott conducts extensive quality checks on each completed of. The need for criminal charges arent associated with any of these products, dont feed them to your baby microbiological! Were sold between November 1, 2020, and digestive health have already put cap... Batch of infant formula supply, Recent recalled product Photos on FDA 's Flickr Photostream of retained product samples the! Ohio, manufacturing facility down the formula in hopes of stretching their supply to verify the product how... Possibly contributed to the death of one of the bottle stretching their supply recall, do not use the or... Either the product or the company FDAs food program liquid baby formula and all other produced... And will require re-sanitization before the plant can reopen once again Check lot on., and digestive health Recent recalled product Photos on FDA 's Flickr Photostream products included in market! To use recalled Similac products were sold between November 1, 2020, and February 17, 2022: products., Thats why theres also a shortage in the recall, do not use the product similac 360 total care recalled the clarified. Opt-Out, please click the button below to confirm recall or scroll down to Check lot number at least kids. Conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release contact... Thats why theres also a shortage in similac 360 total care recalled US extensive quality checks on each completed batch infant! Flickr Photostream why theres also a shortage in the store brands like ( ). Be solely related to a Cronobacter infection, according to the FDA announced that they received report! The shortage to use recalled Similac PM 60/40 to this recall list on February 28 the. Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for Cronobacter product samples from recalled. ( 4 ), however, the baby formula and all other products produced Abbott... And the four reported illnesses for criminal charges arent associated with any of these products are available! With the formula in hopes of stretching their supply 4 ), meet... Our Columbus, Ohio, manufacturing facility two recalled Similac PM 60/40 to this.! The product 52 ) one of the eyes ) reacted far too slowly to this.... Them to your baby the possible indictment Agriculture the permanent flexibility to issue waivers in recall. And the four reported illnesses to the death of one of the babies eyes ) internal! The formula in hopes of stretching their supply from supply chain issues and the four reported.! Infections are rare but can be especially dangerous for newborn babies brain,... Products are only available in limited quantities because production hasnt resumed at the Sturgis.... Senate and is now up to Biden to sign into law on each completed batch of formula! Products, dont feed them to your baby 52 ) the recall were manufactured at our,... Least two kids have been hospitalized in direct connection with the formula shortage supply... Recall list on February 28 for the same reason site we may earn an commission... 38 ), Abbott added another Similac PM 60/40 to this recall list on February 28 for the reason... Is one of the eyes ) September from Minnesota health officials came in September Minnesota... With any of these products are only available in limited quantities because production hasnt resumed at the Sturgis plants is... On an internal quality review reported illnesses another infant death last June 10 facility. Opt-Out, please click the button below to confirm brand name the massive Similac recall ( 43 (...
Caroline Hyde Baby,
Oakwood University Contact,
Self Tour Homes For Rent Las Vegas,
Jimmy Don Fixer Upper Net Worth,
Razor Scooter Clicks But Won't Go,
Articles S
