Cronobacter infections are rare but can be especially dangerous for newborn babies. I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. However, the recall and Abbotts plant closure elevated Enfamil to the top spot with 50% of the market share, Reckitt Benckiser claims. 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. 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. It also called for the appointment of a strong leader and the reorganization of the FDAs food program. (28), However, Abbott denies that the buyback program hurt their products safety. (41), A spokesperson for the hospital refused to disclose the exact number of hospitalized kids but said that all had specific dietary needs. It may cause a decrease in vitamin C levels over time. Abbott assured the public that they are taking this very seriously and working closely with the FDA to implement corrective actions. (51)(52). (30), She further explained that its important to solve the problem as soon as possible. (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. Abbott added another Similac PM 60/40 to this recall list on February 28 for the same reason. (31), Through the Operation Fly Formula, the first batch of formulas (78,000 lbs) arrived in the US to supply specialty infant formula. Any changes to their formula need to be carefully monitored to make sure they could be well tolerated. (1). The .gov means its official.Federal government websites often end in .gov or .mil. (62), Possible contamination with black polyvinyl chloride plastic particles (61), Similac Advance with Iron Formula Powder (12.9-ounce cans). Recalls. Similac, by Abbott Laboratories, is one of the leading infant formula brands in the US. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (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. (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. 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. 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. (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. (51)(52). On February 18, Abbott brand powdered infant formula products sold across the country have been flagged and recalled by the CIFA as there is the possibility of Cronobacter sakazakii and . The following are affected by this recall: (2). Some areas of the Abbott plant were flooded and will require re-sanitization before the plant can reopen once again. (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. that first started with supply chain issues. Have there been any formula recalls? . During testing in our Sturgis, Michigan, facility, we found evidence ofCronobacter sakazakiiin the plant in non-product contact areas. (31). 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. This investigation is ongoing. (19). (35), The bill passed in the House with a large bipartisan majority vote. 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(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. 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 , The recalled products didnt meet FDA requirements because the company didnt submit pre-market notifications. (56), The Similac recall involved dozens of different lots and products. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. The recall does not include any metabolic deficiency nutrition formulas. 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. We want to extend our heartfelt sympathies to the family. (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. 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. It also does not include any amino acid-based formulas or metabolic nutrition formulas. There isnt any recent Parents Choice formula recall (only a Walmart pull-out of Parents Choice wipes). (7). 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. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. hide caption. 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). Safety Alerts, Ready-to-feed liquid products for infants and children, An official website of the United States government, : Rakeen Mabud, the groups chief economist, pointed out that instead of improving its plant and making productive investments, Abbott chose to prioritize its shareholders. Contact the store or manufacturer for the refund or replacement process. (1) Its competitor, Enfamil by Mead Johnson, may also hold around 40% of the market, while Gerber comes in third with roughly 15%. 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. Still, the experience pushed economists to call for bans on buybacks, stricter antitrust enforcement, and limits on shareholder dividends. (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. Those infected with salmonella might experience fever, diarrhea and abdominal cramps. (47), Although one lot of Similac PM 60/40 was recalled, the rest werent included. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. 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. iPhone users should open in Safari. Moms may have different reasons for choosing a particular formula for their babies. (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). 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. The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA. Infant Formula Supply, Recent Recalled Product Photos on FDA's Flickr Photostream. According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. (34), They have also increased production and worked round the clock to help meet the demand. (61), The contamination was attributed to a manufacturing problem, but no serious health problems were reported concerning this recall. Otherwise, click Cancel to return to your profile. 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. (2). 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. 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. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. (13), 750,000 cans of Danone formula, which is equivalent to 19 million 8-ounce bottles, will arrive from their manufacturing facility in Ireland in July. 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. It will take around three weeks or June 20 before these formulas will hit market shelves. All finished infant formula powder products are tested forCronobacter,Salmonella,and other pathogens, and they must test negative before the product is released. 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. (45), For faster production, the Biden administration asked manufacturers to simplify product offerings. 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. "We value the trust parents place in us for high quality and safe nutrition," Abbott said in a statement provided to NPR. Enfamil NeuroPro Sensitive 19.5 oz . (1), Babies can experience vomiting, diarrhea, and gastrointestinal symptoms if they consumed the spoiled products. The shipment was taken to the Nestle distribution center about a mile away for standard quality control checks. We are voluntarily initiating this recall because a small percentage of bottles in the recalled lots have bottle caps that may not have sealed completely, which could result in product spoilage. Although the indictment might be necessary to prevent a similar shortage from happening again, urgent action is necessary to protect the hungry, crying babies. As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. The massive recalls worsened the formula shortage in the US that first started with supply chain issues. 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. (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. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. Double-check the full product name, lot code, batch number, and the expiration or use by date. powdered infant formulas) was issued on February 17 due to possible contamination with. A company spokesperson explained that their strong balance sheet allowed them to invest in improving their facilities even with the stock buybacks. Contains no artificial growth hormones and is non-GMO. Amid the formula shortage following the massive Similac recall earlier this year, many parents continue to face challenges in finding products for their children. 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. (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. This can result in spoilage. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport. (1). (42), Crouse added that there were also some parents who watered down the formula in hopes of stretching their supply. Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. (2)(3). (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. Withdrawals, & (19). (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. These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. On February 18, the Canadian Food Inspection Agency (CFIA) issued a recall for certain Abbott brand Similac powdered . If you have any of these products, dont feed them to your baby. Theyre currently working with the FDA to implement corrective actions at the plant before they can resume production. Now you can switch to digital savings by phone on your favorite formulasheres how: Thanks, but I'll stick with paper for now. According to Dr. Corkins, the preschooler has been admitted since April and remains at the hospital, while the toddler was only hospitalized for about a week. Heres Everything You Need To Know, Nutricia Formula Wasnt Recalled in 2022, However It Did Test Positive For Cronobacter. 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. 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 . (1) Is Similac formula good for babies? 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. (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. 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. 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. 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. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. Before sharing sensitive information, make sure you're on a federal government site. 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. "We'll do whatever it takes to keep that trust and resolve this situation. It also does not include any amino acid-based formulas or metabolic nutrition formulas. Theyre also asking for answers to get to the bottom of the problem and to ensure that infant formula contaminations wouldnt happen again. I am equally concerned that the FDA reacted far too slowly to this report. When you buy through links on our site we may earn an affiliate commission. Retail companies like Walmart have already put a cap on how many you can buy per transaction. (31). The following formulas havent been recalled: Always make sure to check with your babys pediatrician before starting or switching formulas. After President Joe Biden announced Operation Fly Formula, several shipments have arrived from across the world to help the US solve the formula shortage. A review of Abbott's records show that the company has destroyed products in the past due to the presence of Cronobacter. Select Similac baby products are part of a new recall. (6), He explained that he inherited the decentralized structure of the foods program, which kept his office from functioning as an integrated team and subsequently protecting the public. powder . First European Shipment Arrives In The US, House Passes $28 Million Emergency Spending & WIC Flexibility Bills. It can even lead to an imbalance in your babys body that might cause their heart to stop. (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. If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. 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. (31), The company representative added that theyre checking if they could tap into the Nestle global nutrition network for other formulas they could import after the FDA announced that companies are given temporary flexibility for importing baby formulas to address the shortage. 03518QU (manufacturing date March 2019; expiration date March 2022). (4). This is subject to the FDAs approval. Its unclear why that happened, but the FDA hasnt issued a statement regarding this possible judgment lapse. 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. (50), The company insists that despite their products being the center of the issue, their investigations showed these arent the source of the infections. (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. These were loaded on one C-17 cargo plane at Ramstein Air Base in Germany and flown to Indianapolis. 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. (28), American Economic Liberties Project senior fellow Moe Tkacik accused companies like Abbott of using their products as a personal ATM. (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. Still, parents are also having trouble finding these products for their babies. (1). (56), The recall was based on an internal quality review. They can also find it from the list that the company later released. It was also quickly approved by the Senate and is now up to Biden to sign into law. bacteria, which caused serious infections. If spoiled product is consumed, gastrointestinal symptoms such as diarrhea and vomiting may occur. (57)(58), No liquid formula products were included in this recall. Theyre now investigating the circumstances of the babys death. The other reports were made from Ohio and Texas in the following months. (6), In response, deputy commissioner Frank Yiannas of the FDAs Office of Food Policy and Response submitted his resignation, effective February 24. 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. 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. While Abbott's testing of distributed product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. This recall doesnt include any metabolic deficiency nutrition formulas, Abbott liquid formulas, or other nutrition products. By opting-out, you are removing your phone number from your Similac profile. Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. 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. 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. (38), To meet the demands, Enfamil production has been increased to 30%, the company added. 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. (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. (28), Then, the company allegedly increased its dividends by over 25% and offered shareholders a stock buyback program worth $5 billion. One of the cases was fatal. 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. Additionally,recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative forCronobacter. Similac 360 Total Care Sensitive . Two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles in contact! The demand to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles lbs equivalent to approximately 4 eight-ounce... 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