One of the cases was fatal. Contains no artificial growth hormones and is non-GMO. (53), Also, some of the formulas have low iron levels that didnt meet the minimum of 1 mg iron per 100 calories. She encourages parents and caregivers to ask their pediatrician before giving any kind of formula substitute to their babies. The recall does not include any metabolic deficiency nutrition formulas. (45), According to the White House fact sheet, some unscrupulous retailers or individuals used the formula shortage to hoard products from legitimate suppliers. 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. We found no evidence ofSalmonellaNewport. Thats why theres also a shortage in the store brands like Walmarts Parents Choice formulas produced by Perrigo. 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. 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. 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. Around 50% of the market demand comes from the WIC program (Special Supplemental Nutrition Program for Women, Infants, and Children). 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 . (6), The US Justice Department, through its consumer protection branch, is reportedly conducting a criminal investigation over Abbotts possible role in the formula shortage. In several parts of the US, several babies and even older children have been hospitalized amid the formula shortage. (13). Cronobacter infections are rare but can be especially dangerous for newborn babies. (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. Symptoms may include irritability with generalized tenderness. (31). As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. 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. Similac Pro-Advance Non-GMO Infant Formula with Iron, Earths Best Non-GMO Soy-Based Infant Powder Formula, Else Plant-Based Complete Nutrition for Toddlers, Baby Wipes Recall 2022: Affected Brands & Toxic Products, Similac Pro-Sensitive Vs. Similac Sensitive, Similac Pro-Sensitive Vs. Enfamil Gentlease, Best Materials For Toddler Girl Winter Boots, 4 Essential Oils For Sinus Infection Congestion, 4 Essential Oils For Earache & Ear Infections, 3 Scientifically-Proven Ways To Calm Down An Overactive Amygdala, Interview Series: Serenity Kids' Founders On Raising Healthy & Adventurous Eaters, Parent's Choice Formula Recall 2022 & Baby Food Safety Alerts: What You Need To Know, Formula Recall 2001-2023 & Safety Alerts: Everything You Need To Know, Enfamil Formula Recall 2023 & Tampering Issues: What You Need To Know, Angel Infant Formula Recall 2022: Everything You Need To Know, Nutricia Formula Wasn't Recalled in 2022, However It Did Test Positive For Cronobacter, Everything You Need To Know About The Elecare Recall 2022, Similac Alimentum Recall 2022: What You Need To Know, Baby Formula Shortage 2022: Why Its Happening & What You Can Do, ByHeart Formula Recall 2022: PossibleContamination, Baby Food Recalls: How Toxic Heavy Metals Were Found In Some Of The Most Popular Brands, Whats The Best Wearable Breast Pump? Groups are calling on FDA officials to make food safety a priority to avoid a repeat of the formula crisis. The shutdown came after severe thunderstorms hit Michigan, leading to power outages and flood damage. Several groups are also calling on the FDA to restore the deputy food commissioner position removed during the Trump administration. (40), They relied on the amino acids (building blocks of proteins) from EleCare for nourishment because these dont have to be digested. (48). I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility. (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. (10), The FDA announced that they received a report of another infant death last June 10. Their first shipment will be Aptamil First Infant Milk Stage 1 (formula for healthy babies). (29), Wyden has reportedly requested Abbott for more information regarding their stock buyback program. This recall was done after the death of another infant who tested positive for Cronobacter sakazakii. Abbott also reminds parents and caregivers that Cronobacter sakazakii can be commonly found in the environment and a variety of areas around the home. (32), Another one was hospitalized due to mineral imbalances after their caregiver mixed their own formula. Similac is among the most popular formula brands, but is it a healthy option for your baby? 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. Recalled: Similac Formulas Manufacturer's Recall Notice FDA Recall Notice sold at: Target Stores and Target.com recall date: 2/17/2022 Recall Description For more specific information regarding this recall, visit the government agency or manufacturer website: Product Recall Details Target Item Number: This database includes recalls from Health Canada, the Canadian Food Inspection Agency, and Transport Canada. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. (42). Update password per the new system standards (8 Characters). Retail companies like Walmart have already put a cap on how many you can buy per transaction. 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. Symptoms of a Cronobacter infection include poor feeding, jaundice and grunting breaths, according to the FDA. Follow the directions in the email to reset your password. (20). 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. The company clarified that these products are only available in limited quantities because production hasnt resumed at the Sturgis facility. (1). 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. (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. (45), For faster production, the Biden administration asked manufacturers to simplify product offerings. Why did the FDA not spring into action? that first started with supply chain issues. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. (41)(42). (58), Abbott Laboratories Inc. assured affected customers that their tests showed only 0.16% of the recalled Similac products were contaminated. (7). (37). Additionally,recently tested retained product samples of Similac PM 60/40 Lot # 27032K80 (can) / Lot #27032K800 (case) were negative forCronobacter. And the retained sample related to the complaint forSalmonellaNewport tested negative forSalmonella. Theyre doing it to fulfill the FDAs request. Findings to date include several positive Cronobacter sakazakii results from environmental samples taken by the FDA and adverse inspectional observations by the FDA investigators. In response, Abbott reportedly told the committee that the first report came in September from Minnesota health officials. 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 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. Driving the news: The announcement follows February's massive infant formula recall that led to a nationwide baby formula shortage. Califf announced, instead, that Abbott could restart production in a week or two, pending safety upgrades and certifications. 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. (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. Some might feel more secure choosing a well-known brand name. During testing in our Sturgis, Michigan, facility, we found evidence ofCronobacter sakazakiiin the plant in non-product contact areas. (37). Only the specific brands, types, and sizes listed above are WIC approved. The recall does not include any metabolic deficiency nutrition formulas. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. Two House bills were passed to address the shortage. (45), Abbott Nutrition recently announced that theyre releasing some metabolic nutrition and specialty formulas amid the infant formula shortage. Then, ready-to-feed liquid products (product names listed below) were recalled in October over a manufacturing that might cause spoilage. (37), During the May 2022 hearing, FDA Commissioner Califf and lawmakers agreed that consolidation (strong market players taking over smaller competitions) made the US formula market more vulnerable to disruptions. After dismissal, the employee reportedly made the false allegations and submitted the false report to multiple authorities. 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 FDA requires formula manufacturers to meet this requirement to help prevent iron deficiency anemia, a condition that can lead to irreversible functional development outcomes. (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. Republicans are questioning why the FDA isnt held accountable for the shortage and the possible lapses that led to the deaths of the two babies linked to the Abbott products. 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. (1), These products were distributed to some doctors offices, hospitals, distributors, and retailers in the US, Canada, Puerto Rico, Trinidad & Tobago, Curacao, Barbados, St Thomas, Jamaica, St Croix, Dominican Republic, Panama, Colombia, and Haiti. (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. So, its important to follow the instructions found on the packaging for proper preparation, handling, and storage of all powder formulas to avoid contamination. (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. 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 Recalls and Safety Alerts Database provides easy access to a comprehensive list of recalls, advisories, and safety alerts. Surprisingly, however, the FDA didnt issue a safety notice nor did they stop Abbott from producing formulas until the issues have been resolved. The baby had consumed Similac PM 60/40 from this lot. If your product is affected by this recall, dont use it even if it looks alright. According to the hospital spokesperson, the kids ranged from babies to older children. (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. (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. This investigation is ongoing. (56), It affected products made at a plant in Sturgis, Michigan. (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. (39). These two shipments of Bubs amounted to 380,000 lbs equivalent to approximately 4 million eight-ounce bottles. One grants the secretary of the Department of Agriculture the permanent flexibility to issue waivers in the event of supply disruption. Bing Guan/Reuters 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. 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 can even lead to an imbalance in your babys body that might cause their heart to stop. (21), To prevent a similar shortage from happening again, the bill also requires formula manufacturers to create a contingency plan to protect against supply disruptions in the event of a recall. 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. (32), Importing formulas is one of the Biden administrations measures to help ease the ongoing shortage in the US. 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. This case is under investigation, and at this time the cause of the infantsCronobacter sakazakiiinfection has not been determined. Password reset email has been sent. 83/ounce) Enfagrow Premium Powder Toddler Formula - 32oz . Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. Some of the hospitalized kids suffered malnutrition after taking homemade formula or other inappropriate substitutions. The products included in the recall were manufactured at our Columbus, Ohio, manufacturing facility. (18), None of the DNA sequences in the FDA investigation matched the companys products. Aside from checking the nutritional values and ingredients, its also a good idea to monitor for infant formula product recalls. To find out if the product you have is included in this recall, click on the button below to check your lot number. It will take around three weeks or June 20 before these formulas will hit market shelves. Still, parents are also having trouble finding these products for their babies. At least two kids have been hospitalized in direct connection with the formula shortage. (37). "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. Similac and other formulas will be next in line once production starts. 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. (43). . According to Abbott, it will also resume the production of Similac and other formulas as soon as possible. (46), Retailers like Target, CVS, and Walmart have since put a cap on the number of formula packs that consumers can buy online and from their stores. 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. 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 FDA clarifies that the recall is still in effect even though the investigation is closed. If the product is part of the recall, immediately stop giving it to your child, especially recalled products with Salmonella and other pathogens. 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. It is therefore important to verify the product lot number on the bottom or the side of the bottle. Any changes to their formula need to be carefully monitored to make sure they could be well tolerated. Many European formulas arent approved by the FDA, although many parents still prefer them over US brands. They havent confirmed how many formula units have been recalled. Additionally, as part of Abbotts quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogensin our manufacturing facilities. 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. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. 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. 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. The company assures consumers that they have improved their protocols and systems at the facility. Prevent fake or fraudulent products from reaching store shelves. It was also quickly approved by the Senate and is now up to Biden to sign into law. The FDA said environmental samples from the facility have yielded positive results for the Cronobacter bacteria, but there have been no reports of salmonella so far. (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). "We take our responsibility to deliver high-quality products very seriously," said Joe Manning, executive vice president, nutritional products, Abbott. (31), This next shipment from Ramstein Air Base is expected to land in Pennsylvania for distribution by the Nestle facility in the area. 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 . As of May 8, 2022, market research company Datasembly estimates that 43% of the top-selling formula brands are out of stock. 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. Select Similac baby products are part of a new 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. Overview Searching for a milk formula for your little one, but unsure which one to pick? 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. (1)(2), Parents are advised to check the packaging of their Similac powdered formulas. How many infants were fed contaminated formula during this time? However, Califf reportedly sidestepped these questions by saying that he cant share details of the agencys ongoing investigation. Similac 360 Total Care Sensitive 30.2 oz. Abbott Nutrition acknowledges their role in the infant formula shortage. 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. Otherwise, click Cancel to return to your profile. The site is secure. These were the same products recalled in February 2022 and had the following codes (found at the bottom of the package or container): The store is once again recalling these recalled infant formulas, which shouldnt have been sold back to consumers at all. (26), He explained that none of the data matched between the specimen from the four complaints and of the retained product samples. After the recall, however, they had to try other formula options but were unable to tolerate them, leading to dehydration. . Click Here for Recall Information: 2 fl oz Ready-to-Feed Liquid Recall (Oct 2022) or Powder Formula Recall (Feb 2022). Importantly, no distributed product has tested positive for the presence ofCronobacter sakazakii. Additionally, as part of Abbott's quality processes, we conduct routine testing forCronobacter sakazakiiand other pathogensin our manufacturing facilities. There isnt any recent Parents Choice formula recall (only a Walmart pull-out of Parents Choice wipes). (56), The recall was based on an internal quality review. There werent any new cases identified as part of the investigation. Two recalled Similac products were sold between November 1, 2020, and February 17, 2022:. (11), According to the FDA, the infant death reportedly happened in January. (21), Thanks to these special flights, shipments that normally take two weeks can reach the US within 72 hours. (1) Is Similac formula good for babies? 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. 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. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. Withdrawals, & 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. But something must be done to correct this serious safety concern. However, theyre still running out of formulas. (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. 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. 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