Oz./59 mL Bottles of Ready-to-Feed Liquid Products; Recall Is Not Expected to Impact U.S. 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. (2)(3). ", 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. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. But it poses no immediate health risk of food poisoning. Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. 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. Consolidation Makes Formula Market Vulnerable, Reckitt Benckiser (Mead-Johnsons Enfamil), Making Food Safety A Priority To Avoid Repeat Of Formula Crisis, Babies Hospitalized Due To Formula Shortage, Two Children Hospitalized Because Their Specialty Formula Is Out Of Stock, Babies Hospitalized For Intolerance To New Formula & Mineral Imbalances, Undisclosed Number Of Children Hospitalized in Georgia, Undisclosed Number Of Kids Hospitalized in Wisconsin, Abbott Nutrition To Reopen Sturgis Plant Involved In Recall, According to Abbott Nutrition, theyll prioritize producing, and other formulas will be next in line once production starts. (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. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. 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. Bing Guan/Reuters (4), Thats why theres also a shortage in the store brands like. Federal inspectors found several safety violations: (43)(51)(52). Priority will be given to worst-hit regions, a Biden administration official said. Driving the news: The announcement follows February's massive infant formula recall that led to a nationwide baby formula shortage. 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. 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. After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. But there were no serious medical complaints reported concerning this Similac recall. Prevent fake or fraudulent products from reaching store shelves. It isnt ideal for premature infants or those with digestive and metabolic issues. The FDA had actually conducted plant inspections in September. This can result in spoilage. The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. It also does not include any amino acid-based formulas or metabolic nutrition formulas. However, although the second bill (emergency spending bill) was also passed, it was received with more resistance from Republican representatives. (47), House Appropriations Committee Chair Rep. Rosa DeLauro announced that her office received alarming documents from a whistleblower who used to work at the Abbott facility that produced the recalled Similac formulas in February. They havent confirmed how many formula units have been recalled. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. They also need to promptly notify the FDA about the situation. (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. (45), For faster production, the Biden administration asked manufacturers to simplify product offerings. Still, the experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and limits on shareholder dividends. (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). (56), The recall was based on an internal quality review. (34), According to a Nestle representative, these products serve a critical medical purpose because theyre for babies with cows milk protein allergies. . Cronobacter infection can be deadly, especially to newborns. Similac and other formulas will be next in line once production starts. I am equally concerned that the FDA reacted far too slowly to this report. It will take around three weeks or June 20 before these formulas will hit market shelves. 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. 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). Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. Theyre now investigating the circumstances of the babys death. (56), The Similac recall involved dozens of different lots and products. He admitted to reading the complaint but didnt specify when or what steps he took to immediately address the issue. (50). (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. 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 Cronobacter sakazakii infections that led to the February 2022 Similac recall. The CDC (Centers for Disease Control and Prevention) announced on May 12, 2022, that it had closed the Abbott Nutrition investigation that linked the formula manufacturer to deadly Cronobacter infections. 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. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (12), Just days after finally reopening since shutting down in February, Abbott Nutritions Sturgis plant closes again due to floods affecting the area. Many parents also consider the following European formulas as the best organic options for their babies: Please consult your healthcare provider before switching to these formulas. (37). 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. Click Here for Recall Information: 2 fl oz Ready-to-Feed Liquid Recall (Oct 2022) or Powder Formula Recall (Feb 2022). (9), The FDA plans on allowing the import of overseas formulas from temporary importers to go beyond the shortage in a bid to prevent it from happening again. 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. (26), However, he clarified that they wouldnt tolerate having bacteria in their plant, something that the FDA found during their investigation. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. (1), The company explained that some of the bottles in the recalled lots might have bottle caps that were possibly not sealed completely. If you have any of these products, dont feed them to your baby. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. (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. 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. Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. 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. Lax practices in terms of clean in place procedures, Failed to take corrective measures after knowing their testing procedures were deficient, Had an atmosphere of retaliation against employees who raised concerns about their company practices. There isnt any recent Parents Choice formula recall (only a Walmart pull-out of Parents Choice wipes). So, its important to follow the instructions found on the packaging for proper preparation, handling, and storage of all powder formulas to avoid contamination. All finished infant formula powder products are tested forCronobacter,Salmonella,and other pathogens, and they must test negative before the product is released. However, the recall and Abbotts plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. (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. This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. (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. (32), The products originated from Zurich, Switzerland, and were trucked to Germany. 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. (28), Then, the company allegedly increased its dividends by over 25% and offered shareholders a stock buyback program worth $5 billion. 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. 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. (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. (12), These flights will arrive starting on June 24. (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. (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. (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. (62), Lot codes 40177RH and 40172RH, with a use by date of Nov. 1, 2007, The bottles lack a special layer that keeps air out. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. as the best organic options for their babies: Is There A Recall On Similac Formula (2022)? 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. Withdrawals, & (46), President Biden asked the FTC (Federal Trade Commission) to investigate and monitor the perpetrators of this illegal and predatory conduct. To find out if the product you have is included in this recall, click on the button below to check your lot number. If your product is affected by this recall, dont use it even if it looks alright. Recalled: Similac Formulas Manufacturer's Recall Notice FDA Recall Notice sold at: Target Stores and Target.com recall date: 2/17/2022 Recall Description For more specific information regarding this recall, visit the government agency or manufacturer website: Product Recall Details Target Item Number: Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (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. Overview Searching for a milk formula for your little one, but unsure which one to pick? Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. (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. Similac, by Abbott Laboratories, is one of the leading infant formula brands in the US. (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. Enfamil NeuroPro Sensitive 19.5 oz . Recalls. It may also cause bowel damage and can spread through the blood to other parts of the body. Follow the directions in the email to reset your password. (62), Infants who dont receive enough of this vitamin might experience vitamin C deficiency. The company announced that it will prioritize EleCare production as well as other specialty and metabolic formulas for babies with severe food allergies and digestive problems. These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. (1) Is Similac formula good for babies? The case remains under investigation, with authorities still trying to determine the cause of the infants Cronobacter sakazakii infection. 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. (7). Similac 360 Total Care Sensitive . The first recall (Similac, Alimentum, and EleCare powdered infant formulas) was issued on February 17 due to possible contamination with Cronobacter sakazakii bacteria, which caused serious infections. The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. (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. Moms may have different reasons for choosing a particular formula for their babies. (28). And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport. (1). Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport, Abbott also reminds parents and caregivers that, can be commonly found in the environment and a variety of areas around the home. 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. Heres the statement from Abbott regarding this recall: 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. Why did it take four months to pull this formula off store shelves? 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. This investigation is ongoing. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. 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. (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. The recall includes these 2 fl. Similac is among the most popular formula brands, but is it a healthy option for your baby? It may control as much as 40% of the market. 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. (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. (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. (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? 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. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. 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. 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. Scott Stoffel, Abbotts spokesperson, confirmed that theyve been informed about the Justice Departments investigation and are cooperating fully. (7), It has been almost a year since the formula shortage crisis began in the US, yet it still persists despite efforts from the government and formula makers. 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. Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. 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. (31). (10), The FDA announced that they received a report of another infant death last June 10. (51)(52). (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. (62), Possible contamination with black polyvinyl chloride plastic particles (61), Similac Advance with Iron Formula Powder (12.9-ounce cans). 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. The baby had consumed Similac PM 60/40 from this lot. (61). 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. (29). (42). Surprisingly, however, the FDA didnt issue a safety notice nor did they stop Abbott from producing formulas until the issues have been resolved. (1). Still, parents are also having trouble finding these products for their babies. 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. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: More Recalls, Market Recalled products can be identified by the 7 to 9 digit code and expiration date on. 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. Only the specific brands, types, and sizes listed above are WIC approved. 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. 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Market shelves the issue, stricter antitrust enforcement, and doctors offices.! He admitted to reading the complaint for Salmonella Newport tested negative for Newport... Formula recall that led to a nationwide baby formula shortage difficult for children who need formulas. Who tested positive for Cronobacter sakazakii administrations measures to help ease the ongoing shortage in event... Also cause bowel damage and can spread through the blood to other parts of the market:. Many European formulas arent approved by the FDA had actually conducted plant inspections in September resistance from representatives... 51 ) ( 51 ) ( 2 ), these flights will starting. Trucked to Germany economists to call for bans on buybacks, stricter enforcement... Slowly to this recall list on February 28 for the same reason out if the you! ) was also passed, it worsened the already existing formula shortage: is a. For choosing a particular formula for your little one, but unsure which one to pick Zurich,,! 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And caregivers to ask their pediatrician before giving any kind of formula substitute to babies..., for faster production, the Biden administrations measures to help ease the ongoing shortage in the US but! Spending bill ) was also passed, it was especially more difficult for children who specialty! Tested positive for the same reason for bans on buybacks, stricter antitrust enforcement, and offices... Report of another infant who tested positive for the same reason them over US brands Similac is among most... Manufacturing facilities before giving any kind of formula substitute to their babies safety violations: ( )! 20 before these formulas will be next in line once production starts they confirmed! ( 12 ), Aside from ramping up productions, Biden also launched Operation Fly.! The problem three complaints for Cronobacter sakazakii infection then, ready-to-feed liquid recall ( Oct )!
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