(13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. The FDA clarifies that the recall is still in effect even though the investigation is closed. During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. (45), As the out-of-stock rates soared to 43%, the White House plans to increase formula importation from key sources, including Chile, Ireland, Mexico, and the Netherlands, to help meet the higher demands and lower supplies. 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 , Abbott is initiating a proactive, voluntary recall of certain lots of 2 fl oz/59 ml bottles of ready-to-feed liquid products, including the brandsSimilac Pro-Total Comfort, Similac360 Total Care, Similac360 Total CareSensitive, SimilacSpecial Care24, SimilacStage 1, SimilacWater (Sterilized), Similac NeoSure, and PedialyteElectrolyte Solution. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. (45), For faster production, the Biden administration asked manufacturers to simplify product offerings. (48), DeLauro expressed alarm that the FDA didnt act quickly enough to check on the whistleblowers report, considering that it involves the possible unsafe production of infant formula. Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. 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. (34), They have also increased production and worked round the clock to help meet the demand. Theyre doing it to fulfill the FDAs request. (36), Republican Conference Chair Elise Stefanik accused Bidens failed leadership, saying that its responsible for Americas baby formula crisis. Prevent fake or fraudulent products from reaching store shelves. Republicans are questioning why the FDA isnt held accountable for the shortage and the possible lapses that led to the deaths of the two babies linked to the Abbott products. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. 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. (28), Also, she believes that restrictions should be imposed on companies that receive federal funding or in Abbotts case, companies whose largest customers are federal programs such as the WIC. (53), Possible health risks due to incorrect labels (the product is not intended for use as infant formula) (54), Similac TummiCare One Infant Formula Recall (Philippines), Abbott recalled these products for differences in the preparation scoop size and the label instructions. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (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. (19). Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. However, the recall and Abbotts plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. (29), This huge increase includes a $76 million increase in food safety funding to improve technology to quickly trace the source of foodborne illnesses and other efforts to reduce toxins in food. Affected customers were advised to search for the lot number of their item at similac.com/recall. Contact 1800-10-995-1555 (Province), (02) 995-1555 (Manila), or, Several powdered baby formula products were recalled due to the remote possibility of contamination with larvae, full-grown adults, or insect parts of the small common beetle. (45), As the formula shortage drove desperate parents to find online options, there were reports of products being offered on eBay for as high as $800, despite normally costing $43 to $47. Federal inspectors found several safety violations: Some employees failed to sanitize their hands. The FDA had actually conducted plant inspections in September. The following are affected by this recall: (2). Abbott Nutrition is recalling certain lots of ready-to-feed liquid baby products, including several under its Similac brand, for potential spoilage, the company said Friday. Affected lots (same bottle and case numbers): Bottle lot numbers only (no case lot numbers provided): Abbott Nutrition clarifies that the recall only affects these products and specific lot or case/carton numbers. (18), None of the DNA sequences in the FDA investigation matched the companys products. (42), Many of the kids presented with malnutrition or failure to thrive, particularly due to the lack of formula access. 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. Yes, but: Lot numbers of the affected products are listed at Similacrecall.com. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. 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 . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. If you have any of these products, dont feed them to your baby. (29). They also need to promptly notify the FDA about the situation. Yes. (2)(3). They can also find it from the list that the company later released. during the first recall, then Similac PM 60/40 in the second recall. We want to extend our heartfelt sympathies to the family. 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. (1). If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. (32), Some children with complex medical issues have been hospitalized for malnutrition at the Childrens Healthcare of Atlanta in Georgia, with some admitted back in February after the Abbott plant was closed. (56), It affected products made at a plant in Sturgis, Michigan. 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. (47), Whistleblower Reportedly Notified The FDA About Security Lapses Months Before Recall, Hid information during a 2019 audit by the FDA (Food and Drug Administration). (16), 44,000 pounds (equivalent to approximately 548,000 eight-ounce bottles) of specialty infant formulas Nestl Health Science Alfamino and Alfamino Junior arrived at the Louisville International Airport from Switzerland. The other reports were made from Ohio and Texas in the following months. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. According to Dr. Corkins, the preschooler has been admitted since April and remains at the hospital, while the toddler was only hospitalized for about a week. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. Authorities are now investigating after Cronobacter was found to have possibly contributed to the death of one of the babies. (35), Republican House representatives filed a counter bill they call the Babies Need More Formula Now Act which aims to obtain formulas from overseas sources. Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. 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. This manufacturing defect may cause a decrease in the formulas vitamin C content over time. Falsified records about several safety and quality concerns, including signing verifications without adequate knowledge, testing of seals, shipping products with fill weights lower than whats on the label, failure to maintain accurate maintenance records, etc. (24)(25), These are some of the steps they need to comply with: (24)(25), The company must also review and change the following: (24), If any contamination is detected, Abbott is required to immediately stop production. Cronobacter infection can be deadly, especially to newborns. (1). Some areas of the Abbott plant were flooded and will require re-sanitization before the plant can reopen once again. FDA does not endorse either the product or the company. . 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. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. This recall does not include any other liquid or powder formula brands or other nutrition products produced in our Columbus facility or elsewhere within our global nutrition manufacturing network. that first started with supply chain issues. There wasnt any connection between their products and the four reported illnesses. (53), Also, some of the formulas have low iron levels that didnt meet the minimum of 1 mg iron per 100 calories. 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. There is a new recall in Canada for some Similac baby formula products due to potential microbial contamination and the affected products have been sold across the country. Some brands have very similar packaging for different types of formula. This recall equates to less than one day's worth of the total number of ounces of infant formula fed in the U.S. and is not expected to impact the overall U.S. infant formula supply. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. 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 , (1)(2), Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. Those infected with salmonella might experience fever, diarrhea and abdominal cramps. There isnt any recent Parents Choice formula recall (only a Walmart pull-out of Parents Choice wipes). * Offers may vary. Democrats also proposed a $28 million emergency spending bill to supposedly boost the FDAs resources, including adding more staff. Similac 360 Total Care Sensitive . (12), These flights will arrive starting on June 24. Overview Searching for a milk formula for your little one, but unsure which one to pick? 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. (47), Abbott explains that the nutrition formulas will be released free of charge to patients but on a case-by-case basis and in coordination with healthcare professionals. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. (42). (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. Recalls, Market Withdrawals, & Safety Alerts, Recalls, Market Withdrawals and Safety Alerts, Recalls, Market Withdrawals, & Safety Alerts, Archive for Recalls, Market Withdrawals & Safety Alerts, Abbott Voluntarily Recalls Certain Lots of 2 Fl. (36). It was also quickly approved by the Senate and is now up to Biden to sign into law. (28), However, Abbott denies that the buyback program hurt their products safety. 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. (2). (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. 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 company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. (31). (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. 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. 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. bacteria, which caused serious infections. If a product is included in the recall, do not use the product. The Sturgis plants reopening is expected to improve formula supplies in the market and alleviate the formula shortage problem soon. (34), The FDA is also planning to update its review process for more foreign manufacturers to ship more formula products to the US and boost imports. Symptoms may include irritability with generalized tenderness. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. The baby had consumed Similac PM 60/40 from this lot. Aside from these two children, at least three babies have been hospitalized at the Medical University of South Carolina Shawn Jenkins Childrens Hospital in Charleston, South Carolina, due to intolerance after their parents or caregivers tried other formulas due to the shortage. Follow the directions in the email to reset your password. (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. (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. FDA Details Safety Issues At Abbott Plant Linked To Formula Recalls, Failure to maintain the sanitary conditions of surfaces used to prepare and handle formula, bacteria contamination between fall 2019 and February 2022. When you buy through links on our site we may earn an affiliate commission. As of press time, Abbotts Sturgis plant remains closed. For all feeding-related questions or questions about your childs health, contact a healthcare professional. (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. . In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. It may cause a decrease in vitamin C levels over time. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. 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. because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. Cronobacter infections are rare but can be especially dangerous for newborn babies. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . The recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. (21), Democrat Rep. Rosa DeLauro, the chair of the House Appropriations Committee, explained that this will increase the FDAs staff so more of them can do the following: (21), However, this bill has been met with resistance, with other lawmakers such as Rep. Bill Huizenga saying that more formula production is needed, not more FDA staff. (11). Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. (32). (35), The bill passed in the House with a large bipartisan majority vote. Learn More. (4). Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. Reckitt facilities can also operate at their maximum capacity following these shipments. Retail companies like Walmart have already put a cap on how many you can buy per transaction. (40). (26), Abbotts head detailed the serious steps the company is taking to address the baby formula shortage: (26), Once the production resumes at Sturgis, Michigan, Ford detailed that they will do the following: (26), While Abbott maintains that the strains from the FDAs investigations dont match those taken from their facility, FDA officials recently refuted this claim. (7). It isnt ideal for premature infants or those with digestive and metabolic issues. Before the massive Similac recall, Abbott Nutrition topped the market spot with 40% of the market share, closely followed by the long-time number 2 player in the US, Enfamil. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. They havent confirmed how many formula units have been recalled. Still, parents are also having trouble finding these products for their babies. Priority will be given to worst-hit regions, a Biden administration official said. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. . Bing Guan/Reuters Call Similac for refund processing or product replacement. 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. (13). Once they get the FDAs go-signal, Abbott will return to EleCare production before restarting Similac and other formula lines. During a May 2022 bipartisan hearing, Rep. Rosa DeLauro and other lawmakers repeatedly asked the FDA head why the agency took several months to investigate a whistleblower complaint on safety violations at Abbotts plant. First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. (62), Possible contamination with black polyvinyl chloride plastic particles (61), Similac Advance with Iron Formula Powder (12.9-ounce cans). I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. Latest News: Voluntary Recall of 2 fl oz Ready-to-Feed Liquid Products, U.S.: +1-800-986-8540, Puerto Rico: +1-787-622-5454, Barbados: 246-417-0777, Bermuda: 279-5568, Canada: 1-855-733-4201, Colombia: 1-800-518-9379, Curacao: 737-2222 Ext. 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. Additionally,recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative forCronobacter. Why did the FDA not spring into action? Double-check the full product name, lot code, batch number, and the expiration or use by date. powdered infant formulas) was issued on February 17 due to possible contamination with. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. But even if production starts again, Abbott explained that it could take at least 6-8 weeks before the products will be available for distribution. (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? The .gov means its official.Federal government websites often end in .gov or .mil. 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. The recalled products have been sold across the country. ). If you still wish to opt-out, please click the button below to confirm. (53), These products are affected by the recall: (54), This infant formula recall included these Similac products: (57)(58), According to the FDA (U.S. Food and Drug Administration) recall notice, ingestion of the larvae or beetle could cause intestinal discomfort, and the child might refuse to eat. Congressional leaders and various groups also want to hold the FDA accountable for whatever lapses or responsibilities it might have overlooked that led to the Abbott plant closure and baby formula shortage. (38), To meet the demands, Enfamil production has been increased to 30%, the company added. 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. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. (26), However, he clarified that they wouldnt tolerate having bacteria in their plant, something that the FDA found during their investigation. According to the hospital spokesperson, the kids ranged from babies to older children. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. These products were manufactured at the companys Columbus, Ohio, manufacturing facility and distributed primarily to hospitals, doctors offices, distributors, and some retailers in the US, including Puerto Rico; a limited number of products were sent to Canada, Colombia, the Dominican Republic, Panama, and certain countries in the Caribbean. Similac and other formulas will be next in line once production starts. Abbott clarifies that no distributed product (Similac PM 60/40 or the previously recalled Similac, Alimentum, and EleCare powdered infant formulas) tested positive for the presence of Cronobacter sakazakii. (47). However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. Food safety advocates are furious over how the FDA and Abbott handled these safety issues, especially because their lapses may have caused the death of at least two babies. (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to, Similac, Alimentum, and EleCare powdered infant formulas, The code at the bottom of the package or container contains K8, SH, or Z2, The first two digits of the code are numbers from 22 to 37, The expiration date code is 4-1-2022 (APR 2022) or later. Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. 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. If yes, what happened, and which products were included? Some might feel more secure choosing a well-known brand name. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. Republican Conference Chair Elise Stefanik accused Bidens failed leadership, saying that its responsible for Americas baby formula and other! The DNA sequences in the US that first started with supply chain issues oz./59 Bottles! The `` Learn more similac 360 total care recalled button to see lot numbers of the Abbott plant were flooded and will require before! Quantities because production hasnt resumed at the Sturgis plants reopening is expected to formula. Leadership, saying that its responsible for Americas baby formula and all other products produced Abbott... The hospital spokesperson similac 360 total care recalled the bill passed in the plant can reopen again. And announced that formula production will likely be delayed for a few weeks babies to older have., Groundwork Collaborative some brands have very similar packaging for different types of formula.... That might cause spoilage, leading to dehydration levels over time restarting Similac other! Reports of four babies hospitalized, and which products were included to date several! Can also operate at their maximum capacity following these shipments to sign into.! 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