Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (57), This voluntary recall included up to 5 million Similac powder infant formula units in plastic containers and 8-ounce, 12.4-ounce, or 12.9-ounce cans sold in the US, Guam, Puerto Rico, and some Caribbean countries. (8), After a three-week shutdown following massive floods in the area, the Abbott plant in Sturgis, Michigan, has finally reopened again on July 1, 2022. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. 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. 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. The FDA had actually conducted plant inspections in September. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. Federal inspectors found several safety violations: Some employees failed to sanitize their hands. (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. Abbott Recall | Powder Infant Formulas & 2 fl oz Ready-to-Feed Liquid Products, US - certain lots of Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Pro-Total Comfort, Similac NeoSure, Pedialyte Electrolyte Solution, Canada - 1 lot of Pedalyte Electrolyte Solution; 1 lot of Similac Water (Sterilized), Puerto Rico, Bermuda, Curacao, Trinidad & Tobago, Jamaica - 1 lot of Similac 360 Total Care Sensitive, Puerto Rico, Curacao, Trinidad & Tobago, Barbados, Haiti, St. Thomas, St. Croix - 1 lot of Similac 360 Total Care, Panama - 2 lots of Similac Pro-Total Comfort, Dominican Republic - 1 lot of Similac Stage 1. 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. 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. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. (36), Republican Conference Chair Elise Stefanik accused Bidens failed leadership, saying that its responsible for Americas baby formula crisis. (56), The recall was based on an internal quality review. This investigation is ongoing. The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Once they get the FDAs go-signal, Abbott will return to EleCare production before restarting Similac and other formula lines. (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. 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. (37). 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. Affected products have a code beginning with first two digits of 22 through 37 and containing K8, SH or Z2 and have an expiration date of April 1, 2022, or later. It may also cause bowel damage and can spread through the blood to other parts of the body. There werent any new cases identified as part of the investigation. (28), Two years before the recall, Abbotts net profits increased from $3.6 billion to $7.1 billion, according to Securities and Exchange Commission records. (3), Symptoms of sepsis and meningitis can include: (2). The US formula shortage rates continue to rise, with the number reaching as high as 70% in the week ending on May 22, according to a report from Datasembly. 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. 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. 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 It also does not include any amino acid-based formulas or metabolic nutrition formulas. 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. If your infant is experiencing symptomsrelated toCronobacterorSalmonellainfection,such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, abnormal movements, lethargy, rash, or blood in the urine or stool; contact your health care provider to report their symptoms and receive immediate care. (27), According to Ford, none of the bacterial strains that caused the infection of four infants, killing two babies, were found in Abbotts products. It can even lead to an imbalance in your babys body that might cause their heart to stop. Contains no artificial growth hormones and is non-GMO. We found no evidence ofSalmonellaNewport. Thats why theres also a shortage in the store brands like Walmarts Parents Choice formulas produced by Perrigo. Symptoms of a Cronobacter infection include poor feeding, jaundice and grunting breaths, according to the FDA. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. Many parents are closely monitoring infant formula and. (7), It might have played a big role in the shortage and can be held liable, depending on the outcome of the Justice Departments investigation. It isnt ideal for premature infants or those with digestive and metabolic issues. Thankfully, the children have all been discharged. 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. (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. There wasnt any connection between their products and the four reported illnesses. 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 SimilacPro-Total ComfortTM, Similac360 Total Care, Similac 360 Total Care Sensitive, SimilacSpecial Care24, Similac Stage 1, SimilacNeoSure, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. FDA Details Safety Issues At Abbott Plant Linked To Formula Recalls, Failure to maintain the sanitary conditions of surfaces used to prepare and handle formula, bacteria contamination between fall 2019 and February 2022. It may cause a decrease in vitamin C levels over time. 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. iPhone users should open in Safari. 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. If you have any of these products, dont feed them to your baby. (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. The FDA had actually conducted plant inspections in September. This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. (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. This is in addition to lots of Similac, Alimentumand EleCarepowder formula that were voluntarily recalled on Feb. 17. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. (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. 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. If yes, what happened, and which products were included? (4), Thats why theres also a shortage in the store brands like. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. (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. (47), Although one lot of Similac PM 60/40 was recalled, the rest werent included. 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. This investigation is ongoing. Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. The baby had consumed Similac PM 60/40 from this lot. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. 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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. It was easier to increase the shipments because both were already being imported even before the shortage. 8 oz (6 p ack) ready to feed . (30), She further explained that its important to solve the problem as soon as possible. (35), The bill passed in the House with a large bipartisan majority vote. Recalled products can be identified by the 7 to 9 digit code and expiration date on. (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. (45), The White House released the additional measures they will follow to increase the formula products available without compromising babies safety: (45), The US typically produces nearly all (around 98%) of the infant formulas it needs. Find the answers below. Amid the formula shortage following the massive Similac recall earlier this year, many parents continue to face challenges in finding products for their children. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. 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. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. 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. Similac 360 Total Care Sensitive 30.2 oz. For all feeding-related questions or questions about your childs health, contact a healthcare professional. (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? (47). (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. 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. (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. 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. Directions apply to Chrome onAndroid devices. (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. 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. Similac 360 Total Care Sensitive . But something must be done to correct this serious safety concern. To find out if the product you have is included in this recall, click on the button below to check your lot number. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. hide caption. 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. (37). (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. Driving the news: The announcement follows February's massive infant formula recall that led to a nationwide baby formula shortage. (32). Follow the directions in the email to reset your password. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. ", 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. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. (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. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. (41)(42). 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 , (29). (46), President Biden asked the FTC (Federal Trade Commission) to investigate and monitor the perpetrators of this illegal and predatory conduct. 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. * Offers may vary. Safeguarding Infant Health during the Recall Moms may have different reasons for choosing a particular formula for their babies. 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 , (37). (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. (31), This next shipment from Ramstein Air Base is expected to land in Pennsylvania for distribution by the Nestle facility in the area. Aside from checking the nutritional values and ingredients, its also a good idea to monitor for infant formula product recalls. These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. 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. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: More Recalls, Market The shipment was taken to the Nestle distribution center about a mile away for standard quality control checks. This can result in spoilage. (13). However, although the second bill (emergency spending bill) was also passed, it was received with more resistance from Republican representatives. (34), According to a Nestle representative, these products serve a critical medical purpose because theyre for babies with cows milk protein allergies. (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. We found no evidence of Salmonella Newport. (19). (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. 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. 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. Similac recalls several powdered formulas for possible contamination that can cause Cronobacter sakazakii and Salmonella Newport infection. 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(42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. Two House bills were passed to address the shortage. 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. (53), Formulas that dont meet this requirement need a label indicating that additional iron might be necessary, but the company failed to comply. powdered infant formulas) was issued on February 17 due to possible contamination with. Have there been any formula recalls? The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA. 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. 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. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). Retail companies like Walmart have already put a cap on how many you can buy per transaction. Instead, these products were those put on hold amid the recall. After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. (14)(15), 200,000 8-ounce bottles of Kendamil formulas arrived at Dulles International Airport in Virginia from the United Kingdom. (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). (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. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. The FDA relaxed some regulations to make it easier for foreign companies to import formulas to the US, while also assuring parents that these products meet US standards. Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. 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. 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. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. (38), During the hearing before the House subcommittee, Califf asked lawmakers to increase the agencys budget from last years $2.1 billion to $8.4 billion for food safety and nutrition. (1), ByHeart Whole Nutrition Infant Formula Recall, The Similac Recall & The Formula Shortage (2022), in the US, worried parents are having difficulty finding supplies for their babies. 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. 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. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. The baby had consumed Similac PM 60/40 from this lot. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. It was the facility shut down in February following the massive Similac recall. This recall doesnt include any metabolic deficiency nutrition formulas, Abbott liquid formulas, or other nutrition products. The whistleblower alleged that Abbott Nutrition: (48), The whistleblower claims that this report was submitted to the FDA in October 2021, several months before the deaths of the babies and the February 2022 recall. 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 manufacturer, Abbott Nutrition. Similac and other formulas will be next in line once production starts. Still, the experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and limits on shareholder dividends. 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. The other reports were made from Ohio and Texas in the following months. Prevent fake or fraudulent products from reaching store shelves. (1). How many infants were fed contaminated formula during this time? Photo: Stefani Reynolds / AFP via Getty Images. 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. (1). The shutdown came after severe thunderstorms hit Michigan, leading to power outages and flood damage. 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. 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