This voluntary recall only affected products sold in the Philippines. 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. (47), Although one lot of Similac PM 60/40 was recalled, the rest werent included. Failure to establish a system of process controls that covers all stages of processing to ensure that baby formula doesnt become contaminated due to the presence of microorganisms (e.g., bacteria) in the formula or in its processing environment. This is subject to the FDAs approval. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". Inspect domestic and international suppliers. (7). You can check if your powdered formula is affected by inspecting the code printed near the expiration date. (56), The Similac recall involved dozens of different lots and products. 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. I am equally concerned that the FDA reacted far too slowly to this report. The baby had consumed Similac PM 60/40 from this lot. (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. But something must be done to correct this serious safety concern. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. (1) Its competitor, Enfamil by Mead Johnson, may also hold around 40% of the market, while Gerber comes in third with roughly 15%. 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. For all feeding-related questions or questions about your childs health, contact a healthcare professional. 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. ", 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. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: More Recalls, Market , which shouldnt have been sold back to consumers at all. 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. (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. 83/ounce) Enfagrow Premium Powder Toddler Formula - 32oz . The other reports were made from Ohio and Texas in the following months. Overview Searching for a milk formula for your little one, but unsure which one to pick? 03518QU (manufacturing date March 2019; expiration date March 2022). (51)(52), The FDAs preliminary findings show the following: (51)(52), The Senate health committee asked Abbott to detail the amount of time it took them to start the recall from the first reported case. iPhone users should open in Safari. (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. 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. But these include Similac. Federal inspectors found several safety violations: (43)(51)(52). (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. 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. Have there been any formula recalls? Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. The recall does not include any metabolic deficiency nutrition formulas. Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : powder . (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. 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. They can also find it from the list that the company later released. (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. 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. Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. (35), The bill passed in the House with a large bipartisan majority vote. (56), It affected products made at a plant in Sturgis, Michigan. (57)(58), No liquid formula products were included in this recall. 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. Rakeen Mabud, the groups chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. (59), When we identified this, we did extensive testing of every product on the (factory) line, and more than 99.8 percent of the product was negative for beetle contamination, said Abbott spokeswoman Melissa Brotz. 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. 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. (32), Another shipment with 114 pallets of Gerber Good Start Extensive HA formula from the Netherlands is expected to arrive via the second flight of Operation Fly Formula. (31). Enfamil NeuroPro Sensitive 19.5 oz . Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. The baby had consumed Similac PM 60/40 from this lot. However, theyre still running out of formulas. During a May 2022 bipartisan hearing, Rep. Rosa DeLauro and other lawmakers repeatedly asked the FDA head why the agency took several months to investigate a whistleblower complaint on safety violations at Abbotts plant. 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. (16), 44,000 pounds (equivalent to approximately 548,000 eight-ounce bottles) of specialty infant formulas Nestl Health Science Alfamino and Alfamino Junior arrived at the Louisville International Airport from Switzerland. She added that buybacks were considered a form of manipulation and were illegal until 1982. (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. (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. Instead, these products were those put on hold amid the recall. (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. (32), The products originated from Zurich, Switzerland, and were trucked to Germany. (28), House Speaker Nancy Pelosi said that there might be a need for indictment after the nationwide baby formula shortage is resolved. Select Similac baby products are part of a new recall. (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. 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. 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. 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. Contact the store or manufacturer for the refund or replacement process. (13), The company needs to conduct comprehensive testing with an independent third party to determine if the plant is safe to reopen. Abbott Nutrition acknowledges their role in the infant formula shortage. (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. If you still wish to opt-out, please click the button below to confirm. 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 . The case remains under investigation, with authorities still trying to determine the cause of the infants Cronobacter sakazakii infection. (14)(15), 200,000 8-ounce bottles of Kendamil formulas arrived at Dulles International Airport in Virginia from the United Kingdom. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. (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. Between the lines: Abbott said the recall "does not include any other liquid or powder formula brands or other nutrition products produced in our Columbus facility or elsewhere within our global nutrition manufacturing network. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. (28), This alarmed progressive economic advocacy group, Groundwork Collaborative. Some might feel more secure choosing a well-known brand name. (56), The formula has a much lower iron content than the concentration indicated on the label. It was also quickly approved by the Senate and is now up to Biden to sign into law. (34), According to a Nestle representative, these products serve a critical medical purpose because theyre for babies with cows milk protein allergies. It may control as much as 40% of the market. (1)(2), Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. It also does not include any amino acid-based formulas or metabolic nutrition formulas. (27), According to Ford, none of the bacterial strains that caused the infection of four infants, killing two babies, were found in Abbotts products. Cronobacter infections are rare but can be especially dangerous for newborn babies. (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. (53), Possible health risks due to incorrect labels (the product is not intended for use as infant formula) (54), Similac TummiCare One Infant Formula Recall (Philippines), Abbott recalled these products for differences in the preparation scoop size and the label instructions. 02.28.2022 UPDATE: Abbott is voluntarily recalling one lot of Similac PM 60/40 (Lot #27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. (55), The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your babys normal growth. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. 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. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. Why did the FDA not spring into action? But there were no serious medical complaints reported concerning this Similac recall. Although the formula shortage began in 2021, Abbotts massive recall worsened the problem. This manufacturing defect may cause a decrease in the formulas vitamin C content over time. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. 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. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. We want to extend our heartfelt sympathies to the family. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. With the ongoing infant milk formula shortage in the US, worried parents are having difficulty finding supplies for their babies. 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. (1)(2), Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (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. 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. (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. If you have any of these products, dont feed them to your baby. powdered infant formulas) was issued on February 17 due to possible contamination with. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. 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