To find out if the product you have is included in this recall, click on the button below to check your lot number. The products included in the recall were distributed primarily to hospitals and to some doctors offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago. According to the recall advisory, products from Abbott Nutritions Sturgis, Michigan facility have been distributed across the US and likely to have been exported to other countries. If a product is included in the recall,do not use the product. (26), However, he clarified that they wouldnt tolerate having bacteria in their plant, something that the FDA found during their investigation. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. 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. We found no evidence of Salmonella Newport. The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of our Sturgis facility and has not been linked to the two available patient samples or any other known infant illness. What they're saying: "These products are being recalled because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage," the company said in a statement. (1), ByHeart Whole Nutrition Infant Formula Recall, The Similac Recall & The Formula Shortage (2022), in the US, worried parents are having difficulty finding supplies for their babies. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. 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. Abbott is continuing production of Similac 2 fluid ounce/59 milliliter Ready-to-Feed liquid formula products for hospitals and healthcare providers' offices on a different production line. The baby had consumed Similac PM 60/40 from this lot. (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. Thankfully, the children have all been discharged. Follow the directions in the email to reset your password. (4), Thats why theres also a shortage in the store brands like. (46), Retailers like Target, CVS, and Walmart have since put a cap on the number of formula packs that consumers can buy online and from their stores. (1)(2), Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. (1). Similac infant formula will be produced in "alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network," Abbott said. Why did the FDA not spring into action? We are voluntarily initiating this recall because a small percentage of bottles in the recalled lots have bottle caps that may not have sealed completely, which could result in product spoilage. The first recall (Similac, Alimentum, and EleCare powdered infant formulas) was issued on February 17 due to possible contamination with Cronobacter sakazakii bacteria, which caused serious infections. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . 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. It may also cause bowel damage and can spread through the blood to other parts of the body. Learn More. (32). 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. If your infant is experiencing symptomsrelated toCronobacterorSalmonellainfection,such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or stool; contact your health care provider to report their symptoms and receive immediate care. (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. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. On February 18, Abbott brand powdered infant formula products sold across the country have been flagged and recalled by the CIFA as there is the possibility of Cronobacter sakazakii and . Some options for you to try (US brands), with your pediatricians approval: *Check out our interviews with Serenity Kids founders on their toddler formula, and their baby food pouches. Similac infant formula will continue to be produced in alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. Additionally,recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative forCronobacter. Crouse said that the exact number of children hospitalized relating to the formula shortage isnt available, but its apparent that theyve had several of these admissions. The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of our Sturgis facility and has not been linked to the two available patient samples or any other known infant illness. The products included in the recall were distributed primarily to hospitals and to some doctors offices, distributors and retailers in the U.S., including Puerto Rico; one lot of products was sent to Barbados, Bermuda, Colombia, the Dominican Republic, Haiti, Jamaica, St. Croix and St. Thomas; and two lots were sent to Canada, Curacao, Panama, and Trinidad and Tobago. The action comes after learning of the death of an infant who tested positive forCronobacter sakazakiiand who we were informed had consumed Similac PM 60/40 from this lot. (21), Abbott reportedly enjoyed profits soaring as high as 94% between 2019 and 2021 even as bacteria was detected in its products during the same period. Similac infant formula will continue to be produced in alternative product sizes and formats for delivery to retail locations, in addition to increased production throughout our global manufacturing network. Why did it take four months to pull this formula off store shelves? (32), Another shipment with 114 pallets of Gerber Good Start Extensive HA formula from the Netherlands is expected to arrive via the second flight of Operation Fly Formula. (7), It might have played a big role in the shortage and can be held liable, depending on the outcome of the Justice Departments investigation. The whistleblower alleged that Abbott Nutrition: (48), The whistleblower claims that this report was submitted to the FDA in October 2021, several months before the deaths of the babies and the February 2022 recall. 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. (34), They have also increased production and worked round the clock to help meet the demand. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. The recall does not include any metabolic deficiency nutrition formulas. Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. (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. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. (42). Bing Guan/Reuters (5)(45), The White House explains that manufacturers typically produce the same formula type in various package sizes to meet the demand. Many parents are closely monitoring infant formula and baby food recalls because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. Before sharing sensitive information, make sure you're on a federal government site. But there were no serious medical complaints reported concerning this Similac recall. However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. It also does not include any amino acid-based formulas or metabolic nutrition formulas. 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 Comfort TM, Similac 360 Total Care , Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac NeoSure , You can find more information about these recalls below. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. This investigation is ongoing. (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. . 2 fl oz ready-to-feed liquid products included in this voluntary recall: Its important to note that not all recalled products were distributed in all countries and not all 2 fl oz/59 ml formulas are included in the recall. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. (49). (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. The FDA clarifies that the recall is still in effect even though the investigation is closed. For all feeding-related questions or questions about your childs health, contact a healthcare professional. Still, the experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and limits on shareholder dividends. iPhone users should open in Safari. For all feeding-related questions or questions about your childs health, contact a healthcare professional. He admitted to reading the complaint but didnt specify when or what steps he took to immediately address the issue. The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. (46), President Biden asked the FTC (Federal Trade Commission) to investigate and monitor the perpetrators of this illegal and predatory conduct. 360 Whole-Baby Support: Nutrition designed for immune support, brain development, and digestive health; Helps Strengthen the Immune System: Similac 360 Total Care is designed to help strengthen baby's immune system; Convenient & Ready to Use: Great for on-the-go and late-night feeding; no mixing required The company assures consumers that they have improved their protocols and systems at the facility. 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. (7). that first started with supply chain issues. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. This can result in spoilage. If you still wish to opt-out, please click the button below to confirm. 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. (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. Consolidation Makes Formula Market Vulnerable, Reckitt Benckiser (Mead-Johnsons Enfamil), Making Food Safety A Priority To Avoid Repeat Of Formula Crisis, Babies Hospitalized Due To Formula Shortage, Two Children Hospitalized Because Their Specialty Formula Is Out Of Stock, Babies Hospitalized For Intolerance To New Formula & Mineral Imbalances, Undisclosed Number Of Children Hospitalized in Georgia, Undisclosed Number Of Kids Hospitalized in Wisconsin, Abbott Nutrition To Reopen Sturgis Plant Involved In Recall, According to Abbott Nutrition, theyll prioritize producing, and other formulas will be next in line once production starts. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (56), The recall was based on an internal quality review. (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. (44). (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. The shutdown came after severe thunderstorms hit Michigan, leading to power outages and flood damage. The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Why did the FDA not spring into action? The FDA relaxed some regulations to make it easier for foreign companies to import formulas to the US, while also assuring parents that these products meet US standards. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. (51)(52). 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