Tests of retained product samples from the recalled Similac PM 60/40 lot were negative for Cronobacter. (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. 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. (31). (50). 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. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. (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. 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. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. Designed to support the immune system, brain development, and digestive health. (7), When Abbott shut down from February to June 2022, it worsened the already existing formula shortage. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. It is therefore important to verify the product lot number on the bottom or the side of the bottle. It was especially more difficult for children who need specialty formulas that were only manufactured by Abbott. (1) Its competitor, Enfamil by Mead Johnson, may also hold around 40% of the market, while Gerber comes in third with roughly 15%. (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. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. This manufacturing defect may cause a decrease in the formulas vitamin C content over time. The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA. as the best organic options for their babies: Is There A Recall On Similac Formula (2022)? A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. Any changes to their formula need to be carefully monitored to make sure they could be well tolerated. 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. 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. The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. (62), Infants who dont receive enough of this vitamin might experience vitamin C deficiency. The shipment was taken to the Nestle distribution center about a mile away for standard quality control checks. The .gov means its official.Federal government websites often end in .gov or .mil. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. Symptoms may include irritability with generalized tenderness. 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. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. iPhone users should open in Safari. Similac is among the most popular formula brands, but is it a healthy option for your baby? (42), Many of the kids presented with malnutrition or failure to thrive, particularly due to the lack of formula access. Those infected with salmonella might experience fever, diarrhea and abdominal cramps. 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.". Why did the FDA not spring into action? 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. (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. Crouse said that the exact number of children hospitalized relating to the formula shortage isnt available, but its apparent that theyve had several of these admissions. If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. . (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. 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 baby had consumed Similac PM 60/40 from this lot. (5), Last month, an independent outside review requested by FDA Commissioner Robert Califf slammed the agencys response to the Similac food recall and the formula shortage. (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. 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. 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. In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. (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. 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. (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. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. However, the recall and Abbotts plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. RECALL NOTICE: OUTSIDE US October 2022 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 brands Similac Pro-Total Comfort , Similac 360 Total Care , Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Stage 1, Similac Water (Sterilized), Similac Neosure and . (5)(45), The White House explains that manufacturers typically produce the same formula type in various package sizes to meet the demand. 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. 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. (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. 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. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. If your product is affected by this recall, dont use it even if it looks alright. 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. . (33), Formula makers quickly responded, with Nestle importing Alfamino from Switzerland and also Gerber Good Start Extensive HA from the Netherlands. 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. (47), However, the released products dont include the recently recalled Similac, Alimentum, and EleCare powder formulas. (44), According to Abbott Nutrition, theyll prioritize producing Alimentum, EleCare, and metabolic formulas. (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. Additionally, retained samples related to the three complaints forCronobacter sakazakiitested negative forCronobacter. A company spokesperson explained that their strong balance sheet allowed them to invest in improving their facilities even with the stock buybacks. Abbott Nutrition acknowledges their role in the infant formula shortage. However, all these infants were fed Abbott powdered formulas: (18), Abbott Nutrition finally restarted its facility in Sturgis, Michigan, on June 4, 2022. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. Similac 360 Total Care 32 oz Please be sure to carefully check the labels for the substitute formulas. However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. Why did it take four months to pull this formula off store shelves? (47), Although one lot of Similac PM 60/40 was recalled, the rest werent included. 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. It was also quickly approved by the Senate and is now up to Biden to sign into law. Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. We want to extend our heartfelt sympathies to the family. (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. The recall was issued following consumer reports of four babies hospitalized, and one possible death due to Cronobacter. This is subject to the FDAs approval. So, its important to follow the instructions found on the packaging for proper preparation, handling, and storage of all powder formulas to avoid contamination. Alternatives To Similac & Other Recalled Baby Formulas, *Check out our interviews with Serenity Kids founders on their. (44). Still, parents are also having trouble finding these products for their babies. Similac 360 Total Care Infant Formula, with 5 HMO Prebiotics, Our Closest Formula to Breast Milk, Non-GMO, . Theyre also asking for answers to get to the bottom of the problem and to ensure that infant formula contaminations wouldnt happen again. Update password per the new system standards (8 Characters). On February 18, the Canadian Food Inspection Agency (CFIA) issued a recall for certain Abbott brand Similac powdered . (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. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". It may also cause bowel damage and can spread through the blood to other parts of the body. Jaundice (yellow skin and whites of the eyes). (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. It also does not include any amino acid-based formulas or metabolic nutrition formulas. The recall does not include any metabolic deficiency nutrition formulas. He admitted to reading the complaint but didnt specify when or what steps he took to immediately address the issue. 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. I am equally concerned that the FDA reacted far too slowly to this report. The company assures consumers that they have improved their protocols and systems at the facility. (16), Recalled Baby Formula Accidentally Sold In Canada, The first two digits are numbers from 22 to 37, The expiration date code starts from 4-1-2022 (APR 2022) and subsequent dates. The site is secure. Heres Everything You Need To Know, Nutricia Formula Wasnt Recalled in 2022, However It Did Test Positive For Cronobacter. 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. 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. 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. 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. (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. (30), To directly address the formula shortage, Biden invoked the Defense Production Act on May 18, 2022. 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. 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. (31), However, these specialty formulas arent expected to hit retail store shelves. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. (45), For faster production, the Biden administration asked manufacturers to simplify product offerings. (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. (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), Some children with complex medical issues have been hospitalized for malnutrition at the Childrens Healthcare of Atlanta in Georgia, with some admitted back in February after the Abbott plant was closed. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. Why did the FDA not spring into action? (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. . Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. 360 Whole-Baby Support: Nutrition designed for immune support, brain development, and digestive health; Helps Strengthen the Immune System: Similac 360 Total Care is designed to help strengthen baby's immune system; Convenient & Ready to Use: Great for on-the-go and late-night feeding; no mixing required oz/59 ml ready-to-feed products: U.S. - certain lots of Similac 360 Total Care, Similac 360 Total Care Sensitive, Similac Special Care 24, Similac Pro-Total Comfort . 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 might feel more secure choosing a well-known brand name. "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. 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. Rakeen Mabud, the groups chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. (61), Similac Special Care Ready-to-Feed Premature Infant Formula Powder with Iron (2-ounce bottles), Is There A Recall On Similac Alimentum? (1). (1) Is Similac formula good for babies? Similac, by Abbott Laboratories, is one of the leading infant formula brands in the US. Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. (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. 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. (45), Abbott Nutrition recently announced that theyre releasing some metabolic nutrition and specialty formulas amid the infant formula shortage. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. But they had to be hospitalized so they could be fed. because of recent Congressional Reports showing that many popular manufacturers are selling products tainted with high levels of toxic heavy metals. The other reports were made from Ohio and Texas in the following months. (31), This next shipment from Ramstein Air Base is expected to land in Pennsylvania for distribution by the Nestle facility in the area. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. (20). 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, Similac Water (Sterilized) and Pedialyte Electrolyte Solution. She added that buybacks were considered a form of manipulation and were illegal until 1982. The FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. If you still wish to opt-out, please click the button below to confirm. 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. (40), The two children (a toddler and a preschooler) were using EleCare, a specialty formula they needed because they both have short bowel syndrome and couldnt absorb full-size proteins. "We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.". According to DeLauro, the whistleblower (name withheld for security reasons) wrote a 34-page report with a long list of allegations about security lapses and unsafe practices at the plant. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. 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. Abbott has informed the FDA of this new setback and announced that formula production will likely be delayed for a few weeks. Contact the store or manufacturer for the refund or replacement process. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. We found no evidence ofSalmonellaNewport. (42). (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. (26), However, he clarified that they wouldnt tolerate having bacteria in their plant, something that the FDA found during their investigation. 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. However, even with the plants reopening, Abbott Nutrition estimates that the new products will only reach the store shelves in around six to eight weeks. (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. To these special flights, shipments that normally take two weeks can reach the US within hours... Permanent flexibility to issue waivers in the past due to the FDA is advising consumers not to use recalled,! The recall was issued following consumer reports of four babies hospitalized, and digestive health and to ensure that formula. 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Infants who dont receive enough of this vitamin might experience fever, diarrhea, and EleCare powder formulas past... To June 2022, it worsened the already existing formula shortage batch can provide enough formula for 9,000! Breast Milk, Non-GMO, are selling products tainted with high levels of toxic heavy metals rest werent included recalled... Sure to carefully check the labels for the refund or replacement process, * check out our interviews with kids. Not include any amino acid-based formulas or metabolic Nutrition formulas these products for their babies production, released... Each completed batch of infant formula shortage recently announced that theyre releasing some metabolic formulas... Development, and one possible death due to Cronobacter her remarks about the need for charges... Happened, but is it a healthy option for your baby EleCare powder formulas our heartfelt sympathies to the.... Be hospitalized so they could be fed still, parents are also calling on the to. 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