The Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. It also does not include any amino acid-based formulas or metabolic nutrition formulas. Abbott is initiating a proactive, voluntary recall of certain lots of 2 fl oz/59 ml bottles of ready-to-feed liquid products, including the brandsSimilac Pro-Total Comfort, Similac360 Total Care, Similac360 Total CareSensitive, SimilacSpecial Care24, SimilacStage 1, SimilacWater (Sterilized), Similac NeoSure, and PedialyteElectrolyte Solution. (29), This huge increase includes a $76 million increase in food safety funding to improve technology to quickly trace the source of foodborne illnesses and other efforts to reduce toxins in food. The FDA had actually conducted plant inspections in September. (61), The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. What they're saying: "These products are being recalled because a small percentage of bottles (less than 1%) in the recalled lots have bottle caps that may not have sealed completely, which could result in spoilage," the company said in a statement. (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. After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the formula shortage. (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. 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. (31). . 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. hide caption. Abbott assured the public that they are taking this very seriously and working closely with the FDA to implement corrective actions. (51)(52). The .gov means its official.Federal government websites often end in .gov or .mil. (21), Rep. Andy Harris, chair of the Appropriations subcommittee that funds the FDA, claimed that it wasnt a money problem but a leadership issue. But these include Similac, Alimentum, and EleCare during the first recall, then Similac PM 60/40 in the second recall. (45), As the out-of-stock rates soared to 43%, the White House plans to increase formula importation from key sources, including Chile, Ireland, Mexico, and the Netherlands, to help meet the higher demands and lower supplies. The recall does not include any metabolic deficiency nutrition formulas. (19). (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. 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. Click on the "Learn More" button to see lot numbers included in the recall or scroll down to Check Lot Number. Theyre now investigating the circumstances of the babys death. (31), Through the Operation Fly Formula, the first batch of formulas (78,000 lbs) arrived in the US to supply specialty infant formula. Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for Cronobacter. (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. Similac and other formulas will be next in line once production starts. The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of our Sturgis facility and has not been linked to the two available patient samples or any other known infant illness. 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. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. during the first recall, then Similac PM 60/40 in the second recall. 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 , 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. (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. (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. It was also quickly approved by the Senate and is now up to Biden to sign into law. (46), President Biden asked the FTC (Federal Trade Commission) to investigate and monitor the perpetrators of this illegal and predatory conduct. 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). Agriculture Secretary Tom Vilsack explained that this first batch can provide enough formula for around 9,000 babies and 18,000 toddlers for one week. 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. Senate To Investigate Abbotts Safety Improvements & Buyback Program, The Senate Finance Committee recently announced through Senator Ron Wyden that theyre going to investigate Abbotts investments in their plants safety improvements amid record revenues. 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. (11), According to the FDA, the infant death reportedly happened in January. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. (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. Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. (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). However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. 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. 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. (36), Republican Conference Chair Elise Stefanik accused Bidens failed leadership, saying that its responsible for Americas baby formula crisis. because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. 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. But even if production starts again, Abbott explained that it could take at least 6-8 weeks before the products will be available for distribution. (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. (26), Since Abbott has over 40% share of the US infant formula market, their formula recall and subsequent plant shutdown badly affected the formula supply. (12), Just days after finally reopening since shutting down in February, Abbott Nutritions Sturgis plant closes again due to floods affecting the area. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. (2)(3). FDA Commissioner Dr. Robert Califf is the first administration official to face Congress in an investigation of the baby formula shortage. as the best organic options for their babies: Is There A Recall On Similac Formula (2022)? 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. They havent confirmed how many formula units have been recalled. (11). 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. (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. They also need to promptly notify the FDA about the situation. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. They established an IMG (Incident Management Group) to continue working on these supply chain and food safety issues as the out-of-stock rates soared to 43%. This investigation is ongoing. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. Password reset email has been sent. (2). (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. But something must be done to correct this serious safety concern. (5)(43), After getting involved in the massive Similac recall in February 2022, Abbott Nutrition recently announced that it plans to reopen the Sturgis, Michigan plant in about two weeks. This is subject to the FDAs approval. They havent confirmed how many formula units have been recalled. 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 (37). Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. Similac 360 Total Care Sensitive 30.2 oz. Liquid baby formula and all other products produced by Abbott Nutrition are not affected. Theyre doing it to fulfill the FDAs request. (44), Updating the protocols for cleaning, water, and maintenance procedures, Upgrading the facility with the installation of sanitary floors that are easily cleanable and nonporous, Reviewing and updating their training system, education, and all safety procedures applicable for employees and visitors, White House Announces Measures For Formula Shortage, Cracking Down On Price Gouging & Unfair Market Practices, Abbott Nutrition Announces Release Of Some Products Amid Shortage, include the recently recalled Similac, Alimentum, and EleCare powder formulas. Learn More. The case remains under investigation, with authorities still trying to determine the cause of the infants, Abbott clarifies that no distributed product (Similac PM 60/40 or the previously recalled Similac, Alimentum, and EleCare powdered infant formulas) tested positive for the presence of, Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for, Similac Recall February 2022 (First Recall), Similac recalls several powdered formulas for possible contamination that can cause, infection. (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. (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. It also does not include any metabolic deficiency nutrition formulas deputy food Commissioner position removed during Trump. Between November 1, 2020, and EleCare during the first recall, then Similac PM 60/40 the. 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