(44), According to Abbott Nutrition, theyll prioritize producing Alimentum, EleCare, and metabolic formulas. (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. (55), Batch no. Update password per the new system standards (8 Characters). Moms may have different reasons for choosing a particular formula for their babies. The case remains under investigation, with authorities still trying to determine the cause of the infants Cronobacter sakazakii infection. To find out if the product you have is included in this recall, click on the button below to check your lot number. Abbott voluntarily recalled one lot of Similac PM 60/40 with lot #27032K80 (can) or lot # 27032K800 (case) also manufactured in the companys facility in Sturgis, Michigan. The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. It will take around three weeks or June 20 before these formulas will hit market shelves. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. (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. (1), Affected bottle and carton or case lot numbers in the US: (1), Affected lots with the same bottle and case numbers: (1), Bottle lot numbers only (no case lot numbers provided): (1), Carton or case lot numbers only (no bottle lot numbers provided): (1). Although its still unclear what impact this reopening might have on the baby formula shortage, Abbott Nutrition hopes that it can help improve the market supply. 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. (28), However, Abbott denies that the buyback program hurt their products safety. 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 (49). bacteria, which caused serious infections. According to the hospital spokesperson, the kids ranged from babies to older children. 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. powder . The recall includes these 2 fl. (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. Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. (1). (32). 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. (31), The White House further announced that the first round of flights will carry a total amount of formula equivalent to 1.5 million doses of eight-ounce bottles. (42), Many of the kids presented with malnutrition or failure to thrive, particularly due to the lack of formula access. (15), 686,350 cans equivalent to approximately 16.5 million 8 fl oz bottles of Similac NeoSure (for premature babies or low birthweight infants) and Similac Total Comfort (for infants with sensitive tummies) will be imported by Abbott from their manufacturing facility in Granada, Spain, starting in June and throughout the summer. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. Click Here for Recall Information: 2 fl oz Ready-to-Feed Liquid Recall (Oct 2022) or Powder Formula Recall (Feb 2022). Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. 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. FDA Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of the baby formula shortage. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. (47). 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. However, theyre still running out of formulas. 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. Experts point out that baby formula isnt subjected to the same high temperatures that other foods undergo to kill potentially deadly bacteria and other germs. Still, parents are also having trouble finding these products for their babies. hide caption. Similac is among the most popular formula brands, but is it a healthy option for your baby? 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. Similac issued three recall notices in 2022, involving multiple formula products. ). This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. (56), Call 800-986-8850 or visit similac.com/recall (the companys website for recalls), Similac Go & Grow Milk Early Shield Powder, 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. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. 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. (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. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . Driving the news: The announcement follows February's massive infant formula recall that led to a nationwide baby formula shortage. For all feeding-related questions or questions about your childs health, contact a healthcare professional. Follow the directions in the email to reset your password. Cronobacter infection can be deadly, especially to newborns. 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. (28), Then, the company allegedly increased its dividends by over 25% and offered shareholders a stock buyback program worth $5 billion. (32), The products originated from Zurich, Switzerland, and were trucked to Germany. (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. Why did the FDA not spring into action? 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. It can even lead to an imbalance in your babys body that might cause their heart to stop. Now you can switch to digital savings by phone on your favorite formulasheres how: Thanks, but I'll stick with paper for now. Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. Safeguarding Infant Health during the Recall They also need to promptly notify the FDA about the situation. Aside from checking the nutritional values and ingredients, its also a good idea to monitor for infant formula product recalls. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. The FDA had actually conducted plant inspections in September. The USDA (United States Department of Agriculture) is also coordinating with various states to let WIC recipients purchase whatever products are in stock instead of being limited to WIC-approved options. Only the specific brands, types, and sizes listed above are WIC approved. Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. We found no evidence ofSalmonellaNewport. After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. Between the lines: Abbott said the 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. 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. (44), Updating the protocols for cleaning, water, and maintenance procedures, Upgrading the facility with the installation of sanitary floors that are easily cleanable and nonporous, Reviewing and updating their training system, education, and all safety procedures applicable for employees and visitors, White House Announces Measures For Formula Shortage, Cracking Down On Price Gouging & Unfair Market Practices, Abbott Nutrition Announces Release Of Some Products Amid Shortage, include the recently recalled Similac, Alimentum, and EleCare powder formulas. This means you will no longer receive SMS notifications regarding Similac rewards or special offers. Abbott assured the public that they are taking this very seriously and working closely with the FDA to implement corrective actions. (51)(52). Abbott Nutrition issued a voluntary recall of certain lots of ready-to-feed liquid products (2 fl oz or 59 ml bottles), produced at their manufacturing facility in Columbus, Ohio, due to a manufacturing defect. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. 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. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. (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. (31), However, these specialty formulas arent expected to hit retail store shelves. Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. Senate To Investigate Abbotts Safety Improvements & Buyback Program, The Senate Finance Committee recently announced through Senator Ron Wyden that theyre going to investigate Abbotts investments in their plants safety improvements amid record revenues. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. Similac Formula Recall Washington WIC - Temporary Choices for Infant Formula November 1 , 2022 1 Similac Formula Recall - November 1, 2022 . Abbott Nutrition said it is cooperating with the FDA investigation into the three Cronobacter sakazakii infections and one salmonella infection, all of which required hospitalization. To identify if your product is included, please visit similacrecall.com to view a list of impacted lot numbers or use the lot number checker on the webpage. Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : There isnt any recent Parents Choice formula recall (only a Walmart pull-out of Parents Choice wipes). President Joe Biden had previously directed various agencies to import products from companies overseas that meet US standards using military planes through Operation Fly Formula. (21). This investigation is ongoing. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. (16), Recalled Baby Formula Accidentally Sold In Canada, The first two digits are numbers from 22 to 37, The expiration date code starts from 4-1-2022 (APR 2022) and subsequent dates. (1)(2), Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. (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. 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. (27), According to Ford, none of the bacterial strains that caused the infection of four infants, killing two babies, were found in Abbotts products. (37). (1). The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: More Recalls, Market (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. The FDA said environmental samples from the facility have yielded positive results for the Cronobacter bacteria, but there have been no reports of salmonella so far. 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 , During testing in our Sturgis, Michigan, facility, we found evidence ofCronobacter sakazakiiin the plant in non-product contact areas. The baby had consumed Similac PM 60/40 from this lot. 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. . (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. They believe that having a leader in this position can unify and improve the FDAs food program. (10), The agency announced that it will issue further guidance in September regarding how these companies could meet their requirements to continue supplying formulas beyond mid-November. It is therefore important to verify the product lot number on the bottom or the side of the bottle. 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. (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. Foster a culture of compliance to ensure they produce the highest quality baby formulas, Empower workers to identify and report issues that could compromise their products safety and quality. "We'll do whatever it takes to keep that trust and resolve this situation. 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 , (25), Abbott Laboratories CEO Robert Ford apologized for their role in the formula shortage, referring to the massive recall of Similac, Elecare, and Alimentum products in February 2022. Many formulas from name brands like Similac are designed to closely resemble breast milk. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. This voluntary recall only affected products sold in the Philippines. (31), This next shipment from Ramstein Air Base is expected to land in Pennsylvania for distribution by the Nestle facility in the area. Call Similac for refund processing or product replacement. (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. Around 50% of the market demand comes from the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). Amid the formula shortage following the massive Similac recall earlier this year, many parents continue to face challenges in finding products for their children. Similac 360 Total Care Sensitive Milk-based infant formula with iron A 20 Cal/fl oz, nutritionally complete, non-GMO, milk-based, iron fortified infant formula designed for use for sensitive tummies as a milk-based alternative to standard milk-based formulas for sensitive tummies. The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. Democrats also proposed a $28 million emergency spending bill to supposedly boost the FDAs resources, including adding more staff. 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. Meanwhile, Abbott said the 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.". Password reset email has been sent. (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. Recalled products can be identified by the 7 to 9 digit code and expiration date on. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. 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. (45), For faster production, the Biden administration asked manufacturers to simplify product offerings. (38), To meet the demands, Enfamil production has been increased to 30%, the company added. (1), These products were distributed to some doctors offices, hospitals, distributors, and retailers in the US, Canada, Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, Jamaica, St Croix, Dominican Republic, Panama, Colombia, and Haiti. Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. (37), Currently, 90% of the US formula market is dominated by just four players: (37), These four companies also dominate the federal contracts for the WIC program for low-income families, which accounts for 50% of US formula productions. 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. (Liquid Ready-To-Drink Formula), The bottles had a missing special layer that keeps air out. The baby reportedly consumed formula made by Abbott Nutrition. The FDA clarifies that the recall is still in effect even though the investigation is closed. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. Some might feel more secure choosing a well-known brand name. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. The Sturgis plants reopening is expected to improve formula supplies in the market and alleviate the formula shortage problem soon. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. But they had to be hospitalized so they could be fed. 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. 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. 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. 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. Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. 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. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). 02.28.2022 UPDATE: Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot #27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. (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. 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. oz/59 ml ready-to-feed products: U.S. - certain lots of Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Pro-Total Comfort . (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. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. 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. (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. (20). (12), These flights will arrive starting on June 24. RECALL NOTICE: OUTSIDE US October 2022 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 brands Similac Pro-Total Comfort , Similac 360 Total Care , Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac Water (Sterilized), Similac Neosure and . More are expected to arrive on three more flights in the coming weeks. However, even with the plants reopening, Abbott Nutrition estimates that the new products will only reach the store shelves in around six to eight weeks. 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. FDA does not endorse either the product or the company. 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