As of press time, Abbotts Sturgis plant remains closed. Why did the FDA not spring into action? There werent any new cases identified as part of the investigation. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. (12), These flights will arrive starting on June 24. This can result in spoilage. (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. (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. ", What's next: The company said it 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. (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. 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 . 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 The baby had consumed Similac PM 60/40 from this lot. The FDA requires formula manufacturers to meet this requirement to help prevent iron deficiency anemia, a condition that can lead to irreversible functional development outcomes. (28), However, Abbott denies that the buyback program hurt their products safety. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. On February 18, the Canadian Food Inspection Agency (CFIA) issued a recall for certain Abbott brand Similac powdered . The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. (61). Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. Abbott Nutrition acknowledges their role in the infant formula shortage. (42). How many infants were fed contaminated formula during this time? ). (21), Under this act, suppliers must prioritize orders from infant formula manufacturers before any of their other customers who may have ordered the same goods. The company assures consumers that they have improved their protocols and systems at the facility. While Abbott's testing of distributed product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. Formulas still to arrive starting in June or July: The CFIA (Canadian Food Inspection Agency) warned consumers who bought from Shoppers Drug Mart to check their products after the retail pharmacy giant accidentally sold recalled baby formulas from Abbott due to an online error. (17). They believe that having a leader in this position can unify and improve the FDAs food program. According to DeLauro, the whistleblower (name withheld for security reasons) wrote a 34-page report with a long list of allegations about security lapses and unsafe practices at the plant. (49). FDA does not endorse either the product or the company. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. It was easier to increase the shipments because both were already being imported even before the shortage. Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. Enfamil NeuroPro Sensitive 19.5 oz . bacteria, which caused serious infections. (32). Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. 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. Similac Formula Recall Washington WIC - Temporary Choices for Infant Formula November 1 , 2022 1 Similac Formula Recall - November 1, 2022 . The massive recalls worsened the formula shortage in the US that first started with supply chain issues. (56), The Similac recall involved dozens of different lots and products. . 83/ounce) Enfagrow Premium Powder Toddler Formula - 32oz . (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. They havent confirmed how many formula units have been recalled. (39). They havent confirmed how many formula units have been recalled. 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. (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. 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. (Liquid Ready-To-Drink Formula), The bottles had a missing special layer that keeps air out. You can check if your powdered formula is affected by inspecting the code printed near the expiration date. 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. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. (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. If a product is included in the recall, do not use the product. (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. (42). (45), For faster production, the Biden administration asked manufacturers to simplify product offerings. The Sturgis plants reopening is expected to improve formula supplies in the market and alleviate the formula shortage problem soon. Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. There wasnt any connection between their products and the four reported illnesses. This recall doesnt include any metabolic deficiency nutrition formulas, Abbott liquid formulas, or other nutrition products. (31), However, these specialty formulas arent expected to hit retail store shelves. The FDA had actually conducted plant inspections in September. Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. Similac 360 Total Care Sensitive . Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. (1). Nine Baby Deaths Reported During FDA Investigation, From December 1, 2021, to March 3, 2022, the FDA reportedly received a total of nine reports of formula-related baby deaths, with two among the four confirmed, infections that led to the February 2022 Similac recall. (4). It was the facility shut down in February following the massive Similac recall. After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the formula shortage. (28). (1), According to the recall advisory, these are the affected products: (1), Abbott Nutrition clarified that only a small percentage of bottles might have been affected by the manufacturing defect. So, major disruptions of these companies supplies, such as a massive recall like the February 2022 Similac recall, can greatly affect the formula supply in the market. This is in addition to lots of Similac, Alimentumand EleCarepowder formula that were voluntarily recalled on Feb. 17. Retail companies like Walmart have already put a cap on how many you can buy per transaction. Surprisingly, however, the FDA didnt issue a safety notice nor did they stop Abbott from producing formulas until the issues have been resolved. Have there been any formula recalls? 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. 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. (56), It affected products made at a plant in Sturgis, Michigan. . (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. He admitted to reading the complaint but didnt specify when or what steps he took to immediately address the issue. 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. 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. This is subject to the FDAs approval. 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. 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. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. (35), The bill passed in the House with a large bipartisan majority vote. 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Photo: Stefani Reynolds / AFP via Getty Images. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. Similac is among the most popular formula brands, but is it a healthy option for your baby? This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. (36). (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. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. Federal inspectors found several safety violations: (43)(51)(52). (31), Through the Operation Fly Formula, the first batch of formulas (78,000 lbs) arrived in the US to supply specialty infant formula. iPhone users should open in Safari. 235, 205, Dominican Republic: +1-849-200-1564, Haiti: 868-687-0223, Jamaica: 876-927-7098, Panama: 800-0410, St. Croix: 1(340) 690-7222, St. Thomas: 1(340) 690-7222, Trinidad & Tobago: 868-687-0223, Savings on Similac.com Schedule & Save purchases, Choose a preferred retailer, like Amazon or Target. * Offers may vary. Understanding the need for the international community to help solve the US crisis as more babies go hungry, several foreign baby formula companies offered to help. The case remains under investigation, with authorities still trying to determine the cause of the infants Cronobacter sakazakii infection. (60), According to the FDA, premature babies fed with this formula for over a month may have a higher risk of developing iron-deficiency anemia because of insufficient iron intake. This voluntary recall only affected products sold in the Philippines. Some of the companies that offered to help: A consent decree filed at the US District Court for the Western District of Michigan created a legally binding agreement between Abbott and the FDA, with steps that the company had to comply with before production at the Sturgis facility can resume. 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. (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. CNN Abbott Labs said Friday that it is recalling certain lots of 2 fluid ounce/59 milliliter bottles of Ready-to-Feed liquid formula for infants and children due to a problem with the bottle caps. However, the recall and Abbotts plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. 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. 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. Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. 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. 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. (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. 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