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. (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. Affected customers were advised to search for the lot number of their item at similac.com/recall. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. So, major disruptions of these companies supplies, such as a massive recall like the February 2022 Similac recall, can greatly affect the formula supply in the market. All finished infant formula powder products are tested forCronobacter,Salmonella,and other pathogens, and they must test negative before the product is released. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. (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. Meanwhile, Abbott said the 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.". (27), According to Ford, none of the bacterial strains that caused the infection of four infants, killing two babies, were found in Abbotts products. 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. (56), Call 800-986-8850 or visit similac.com/recall (the companys website for recalls), Similac Go & Grow Milk Early Shield Powder, 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. 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. It was easier to increase the shipments because both were already being imported even before the shortage. Abbott Nutrition said it is cooperating with the FDA investigation into the three Cronobacter sakazakii infections and one salmonella infection, all of which required hospitalization. (56), It affected products made at a plant in Sturgis, Michigan. Contains no artificial growth hormones and is non-GMO. The FDA clarifies that the recall is still in effect even though the investigation is closed. 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. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". Similac 360 Total Care * Infant Formula is made with an exclusive blend of 5 HMO prebiotics structurally identical to those in breast milk. This manufacturing defect may cause a decrease in the formulas vitamin C content over time. (1). The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. But they had to be hospitalized so they could be fed. (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. 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. The .gov means its official.Federal government websites often end in .gov or .mil. 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. President Joe Biden had previously directed various agencies to import products from companies overseas that meet US standards using military planes through Operation Fly Formula. (21). (31), However, these specialty formulas arent expected to hit retail store shelves. Theyre also asking for answers to get to the bottom of the problem and to ensure that infant formula contaminations wouldnt happen again. It is therefore important to verify the product lot number on the bottom or the side of the bottle. Abbott Recalls Ready-to-Feed Liquid Products, 39480N200; 420395E00 (also distributed in Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, St Croix, and Haiti), 40561N200 (also sold in Puerto Rico, Curacao, Jamaica, Bermuda, and Trinidad & Tobago), 40749N200 sold in the Dominican Republic, 39398N200 (bottle lot number only) sold in Canada, Similac Recall February 2022 (Second Recall), This recall was done after the death of another infant who tested positive for. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. (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. Before sharing sensitive information, make sure you're on a federal government site. 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. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. Nine Baby Deaths Reported During FDA Investigation, From December 1, 2021, to March 3, 2022, the FDA reportedly received a total of nine reports of formula-related baby deaths, with two among the four confirmed, infections that led to the February 2022 Similac recall. If you have questions, please contact Abbott's Consumer Relations hotlines below in the country where you received product: Join Similac Rewards for up to $400*in benefits and support throughout your journey. The recall includes these 2 fl. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. As of press time, Abbotts Sturgis plant remains closed. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. This can result in spoilage. Experts point out that baby formula isnt subjected to the same high temperatures that other foods undergo to kill potentially deadly bacteria and other germs. Many parents are closely monitoring infant formula and. We found no evidence of Salmonella Newport. . . There wasnt any connection between their products and the four reported illnesses. Find the answers below. 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. (31), Through the Operation Fly Formula, the first batch of formulas (78,000 lbs) arrived in the US to supply specialty infant formula. Learn More. 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. (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. This voluntary recall only affected products sold in the Philippines. Retail companies like Walmart have already put a cap on how many you can buy per transaction. The White House recently announced Operation Fly Formulas tenth flight to Fort Worth, Texas from Mexico, which will bring approximately 1 million pounds (equivalent to around 16 million 8-oz bottles) of Gerber Good Start Gentle infant formula. (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. The FDA issued the recall advisory after four infants from three different states (MN, OH, and TX) fell ill after reportedly consuming Similac powdered infant formula produced in Abbott Nutritions Sturgis, Michigan facility. 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. 02.17.2022 -Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentumand EleCare,manufactured in Sturgis, Michigan, one of the companys manufacturing facilities. 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. (36). (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. (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. Cronobacter infection can be deadly, especially to newborns. This investigation is ongoing. as the best organic options for their babies: Is There A Recall On Similac Formula (2022)? (48). A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. (13). (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. Then, theyre marking these up for online retail at exorbitant prices. (26), However, he clarified that they wouldnt tolerate having bacteria in their plant, something that the FDA found during their investigation. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. (31). The baby reportedly consumed formula made by Abbott Nutrition. It was the facility shut down in February following the massive Similac recall. 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. 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, : Call Similac for refund processing or product replacement. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. (1), According to the recall advisory, these are the affected products: (1), Abbott Nutrition clarified that only a small percentage of bottles might have been affected by the manufacturing defect. Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. 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. He admitted to reading the complaint but didnt specify when or what steps he took to immediately address the issue. Some of these facility improvements include the following: (44), US President Joe Biden met with infant formula manufacturers and retailers, including Reckitt, Gerber, Walmart, and Target, to discuss strategies to get more formula quickly yet safely onto store shelves to solve the ongoing 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. By opting-out, you are removing your phone number from your Similac profile. 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. 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. (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. 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. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. It isnt ideal for premature infants or those with digestive and metabolic issues. If you still wish to opt-out, please click the button below to confirm. (44). (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. 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. 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. (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. Abbott assured the public that they are taking this very seriously and working closely with the FDA to implement corrective actions. (51)(52). Yes. (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. Some might feel more secure choosing a well-known brand name. (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. (31). 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 recalled products have been sold across the country. She added that buybacks were considered a form of manipulation and were illegal until 1982. (1) Is Similac formula good for babies? Many parents are closely monitoring infant formula and baby food recalls because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. (1), Affected bottle and carton or case lot numbers in the US: (1), Affected lots with the same bottle and case numbers: (1), Bottle lot numbers only (no case lot numbers provided): (1), Carton or case lot numbers only (no bottle lot numbers provided): (1). (2). Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. For all feeding-related questions or questions about your childs health, contact a healthcare professional. 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. 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. 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. However, although the second bill (emergency spending bill) was also passed, it was received with more resistance from Republican representatives. 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. Thankfully, the children have all been discharged. Abbott 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. When you buy through links on our site we may earn an affiliate commission. Key ingredients found in breast milk including 5 HMO prebiotics. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. (42). Still, parents are also having trouble finding these products for their babies. (53), Also, some of the formulas have low iron levels that didnt meet the minimum of 1 mg iron per 100 calories. 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. 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. I am equally concerned that the FDA reacted far too slowly to this report. Bing Guan/Reuters One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. 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. Click Here for Recall Information: 2 fl oz Ready-to-Feed Liquid Recall (Oct 2022) or Powder Formula Recall (Feb 2022). Instead, theyll be distributed to pharmacies, hospitals, and doctors offices first. (32), The products originated from Zurich, Switzerland, and were trucked to Germany. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to, Similac, Alimentum, and EleCare powdered infant formulas, The code at the bottom of the package or container contains K8, SH, or Z2, The first two digits of the code are numbers from 22 to 37, The expiration date code is 4-1-2022 (APR 2022) or later. It also does not include any amino acid-based formulas or metabolic nutrition formulas. (37). (55), The formula is safe to consume, but incorrect preparation using the provided scoop might not provide enough nutrients for your babys normal growth. However, the baby formula shortage from supply chain issues and the Similac recalls reduced the available products. (34), They have also increased production and worked round the clock to help meet the demand. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. Abbott is voluntarily recalling these products after four consumer complaints related toCronobacter sakazakiiorSalmonellaNewport in infants who had consumed powder infant formula manufactured in this facility. 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. One of the cases was fatal. (56), The recall was based on an internal quality review. 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. 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. Any metabolic deficiency nutrition formulas healthcare professional reportedly requested Abbott for more information regarding their stock program... 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