If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. Overview Searching for a milk formula for your little one, but unsure which one to pick? bacteria, which caused serious infections. , which shouldnt have been sold back to consumers at all. 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. Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. However, issuing the voluntary recall was the right thing to do because they didnt want to risk the childrens lives and health. Symptoms of a Cronobacter infection include poor feeding, jaundice and grunting breaths, according to the FDA. 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. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. At least two kids have been hospitalized in direct connection with the formula shortage. Contact the store or manufacturer for the refund or replacement process. (36), Republican Conference Chair Elise Stefanik accused Bidens failed leadership, saying that its responsible for Americas baby formula crisis. Yes. If yes, what happened, and which products were included? With the ongoing infant milk formula shortage in the US, worried parents are having difficulty finding supplies for their babies. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. The recall does not include any metabolic deficiency nutrition formulas. 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. 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. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. Some areas of the Abbott plant were flooded and will require re-sanitization before the plant can reopen once again. 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. (2), Cronobacter can cause severe, life-threatening infections such as sepsis or meningitis (inflammation of the membranes protecting the brain and spine), according to the CDC (Centers For Disease Control And Prevention). (21), To prevent a similar shortage from happening again, the bill also requires formula manufacturers to create a contingency plan to protect against supply disruptions in the event of a recall. 03518QU (manufacturing date March 2019; expiration date March 2022). (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. (29). (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. (1). 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 During testing in our Sturgis, Michigan, facility, we found evidence ofCronobacter sakazakiiin the plant in non-product contact areas. 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. (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. 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. They also need to promptly notify the FDA about the situation. Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. (31), Aside from ramping up productions, Biden also launched Operation Fly Formula. He directed various government agencies to use the Department of Defense planes to pick up formulas that meet U.S. standards overseas and fly these to the U.S. to help restock shelves. But there were no serious medical complaints reported concerning this Similac recall. Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. 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 , 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. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. 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. Many formulas from name brands like Similac are designed to closely resemble breast milk. 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. One of the cases was fatal. Designed to support the immune system, brain development, and digestive health. Similac and other formulas will be next in line once production starts. (42). (4), Although the February 2022 Similac recall due to bacterial infections (discussed in detail below) is among the main causes of the formula shortage, authorities explained that supply chain issues and higher demands were already causing a shortage even in 2021. Inspect domestic and international suppliers. (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. The recall does not include any metabolic deficiency nutrition formulas. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. FDA does not endorse either the product or the company. (42). (26), However, he clarified that they wouldnt tolerate having bacteria in their plant, something that the FDA found during their investigation. It also does not include any amino acid-based formulas or metabolic nutrition formulas. Thankfully, the children have all been discharged. (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. It was easier to increase the shipments because both were already being imported even before the shortage. (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. . It isnt ideal for premature infants or those with digestive and metabolic issues. (56), The recall was based on an internal quality review. (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. Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. (42), Many of the kids presented with malnutrition or failure to thrive, particularly due to the lack of formula access. (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. (55), The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your babys normal growth. (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. (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. The FDA had actually conducted plant inspections in September. (29), Califf insisted that theres a need for major improvements at the FDA, not because people were bad but because they needed the right resources and consistent leadership. (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. We found no evidence of Salmonella Newport. Withdrawals, & Additionally,recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative forCronobacter. (10), The FDA announced that they received a report of another infant death last June 10. (37). Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. (61). (13). 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. (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. By opting-out, you are removing your phone number from your Similac profile. (31), However, these specialty formulas arent expected to hit retail store shelves. But these include Similac. (18), None of the DNA sequences in the FDA investigation matched the companys products. The company assures consumers that they have improved their protocols and systems at the facility. (28), Then, the company allegedly increased its dividends by over 25% and offered shareholders a stock buyback program worth $5 billion. 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. It will take around three weeks or June 20 before these formulas will hit market shelves. Childrens Wisconsin warns that homemade formula can cause liver and/or kidney damage. For all feeding-related questions or questions about your childs health, contact a healthcare professional. On February 18, the Canadian Food Inspection Agency (CFIA) issued a recall for certain Abbott brand Similac powdered . (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. Retail companies like Walmart have already put a cap on how many you can buy per transaction. (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. (45), According to the White House fact sheet, some unscrupulous retailers or individuals used the formula shortage to hoard products from legitimate suppliers. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. This voluntary recall only affected products sold in the Philippines. 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. White House National Economic Council director Brian Deese said that the Air Force cargo plane carried 15% of the specialty medical-grade baby formula needed in the US. (28). 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. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). (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. 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. Those infected with salmonella might experience fever, diarrhea and abdominal cramps. (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. 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. (44), According to Abbott Nutrition, theyll prioritize producing Alimentum, EleCare, and metabolic formulas. 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. Photo: Stefani Reynolds / AFP via Getty Images. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. (20). 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. There wasnt any connection between their products and the four reported illnesses. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. (39). Alternatives To Similac & Other Recalled Baby Formulas, *Check out our interviews with Serenity Kids founders on their. Top FDA Official Resigns Over Formula Shortage, Abbott Under Criminal Investigation Over Possible Role In Baby Formula Shortage, Enfamil Maker Believes Shortage Will Last Until Spring, FDA Plans To Allow Overseas Formulas Beyond Shortage, FDA Investigates Another Abbott Formula-related Baby Death, Newly Reopened Abbott Plant Shuts Again Due To Floods, After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the, 95,000 cans arrived in LAX for Walmart, Albertsons Companies, and The Kroger Company grocery stores from Australia. 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. 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. After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. Update password per the new system standards (8 Characters). Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. (34), According to a Nestle representative, these products serve a critical medical purpose because theyre for babies with cows milk protein allergies. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. Our formula also has nutrition designed for immune support, brain development, and digestive health. (19). Moms may have different reasons for choosing a particular formula for their babies. (2). One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. 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. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. (37). (31). 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. 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. Similac powdered baby formula with an expiration date on or after April 1, 2022, and a code with first two digits of 22 through 37 and containing K8, SH or Z2 are part of a voluntary recall by its . (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. However, theyre still running out of formulas. It was the facility shut down in February following the massive Similac recall. 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. They believe that having a leader in this position can unify and improve the FDAs food program. Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. 8 oz (6 p ack) ready to feed . Heres Everything You Need To Know, Nutricia Formula Wasnt Recalled in 2022, However It Did Test Positive For Cronobacter. Abbott assured the public that they are taking this very seriously and working closely with the FDA to implement corrective actions. (51)(52). ). (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. The site is secure. (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. (28), However, Abbott denies that the buyback program hurt their products safety. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. 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. Thats why theres also a shortage in the store brands like Walmarts Parents Choice formulas produced by Perrigo. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. (19). 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. 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. (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. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. (12), These flights will arrive starting on June 24. Cronobacter infection can be deadly, especially to newborns. (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. (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. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. (36). (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. However, she warned that formula dilution can lead to organ failure or brain swelling. because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. The following are affected by this recall: (2). The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. (4). Similac 360 Total Care Sensitive 30.2 oz. 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. Previous investigations by the FDA (Food and Drug Administration) reportedly discovered several violations, including Abbotts lax safety protocols and bacterial contamination at its manufacturing facility. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. (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. The following are some of the baby formulas recalled in 2021: These are imported products from Europe distributed by the online retail store LittleBundle website starting May 20, 2021. Theyre also asking for answers to get to the bottom of the problem and to ensure that infant formula contaminations wouldnt happen again. (11), According to the FDA, the infant death reportedly happened in January. 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. Requested Abbott for more information regarding their stock buyback program hurt their products safety infection can deadly... Diarrhea and vomiting may occur improve the FDAs Food program Wyden has requested... Internal quality review why theres also a shortage in the recall was based on internal... Been sold back to consumers at all, we conduct routine testing for.... 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