Baby food formula recall


Baby formula: Abbott announces another recall but claims it affects small fraction of total US supply

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02:30 - Source: CNN

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 on some bottles that may not have sealed completely and could result in spoilage.

If a child were to consume spoiled formula, the company said, it could cause stomach problems such as vomiting or diarrhea.

Similac and Enfamil products are seen on largely empty shelves in the baby formula section of a Target store, amid continuing nationwide shortages in infant and toddler formula, in San Diego, California, U.S., May 25, 2022. REUTERS/Bing Guan/File Photo

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A company spokesperson told CNN that the recall involves “less than a day’s worth” of the total infant formula used in the US and should not affect the overall supply.

This formula was manufactured in Columbus, Ohio, not at Abbott’s plant in Sturgis, Michigan, that was the focus of a large recall in February that exacerbated a shortage of baby formula, leading to ongoing problems.

The recalled brands include Similac, Pro-Total Comfort, 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.

A customer stands waiting for assistance to receive baby formula in a Walmart Supercenter on July 08, 2022 in Houston, Texas. Consumer goods continue seeing shortages as the country grapples with ongoing supply chain issues stemming from the pandemic.

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Most of these products are distributed primarily to hospitals and doctors’ offices.

The recall does not include any other liquid or powder formula brands or other nutrition products produced at Abbott’s Ohio facility or any other manufacturing location.

Affected lot numbers are listed on the website similacrecall.com. If a consumer has one of the recalled products, they should not feed it to their child, the company said.

“We take our responsibility to deliver high-quality products very seriously,” Joe Manning, Abbott’s executive vice president of nutritional products, said in a news release. “We internally identified the issue, are addressing it, and will work with our customers to minimize inconvenience and get them the products they need.”

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Abbott’s Sturgis plant was shuttered for months after an FDA inspection found Cronobacter sakazakii bacteria, which can be deadly to infants, in several areas. Similac, Alimentum and EleCare powdered infant formulas made at the plant were recalled, and the closure exacerbated shortages caused by supply chain disruptions. Families across the United States have struggled for months to find formula for infants and for people with specific nutrition needs.

Production had been underway for less than two weeks before a storm and flooding in July prompted officials to close the plant again. It was restarted in August.

The Biden administration’s Operation Fly Formula efforts have brought in millions of pounds of imported formula to help with the shortage.

Stock rates for formula have gotten much better, but they are still not back to typical levels before the shortage, according to market research firm IRI.

Powdered Infant Formula Recall: What to Know

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For the latest on infant formula, please visit the FDA webpage, Infant Formula Information and Ongoing FDA Efforts to Increase Supply and the HHS webpage, Information for Families During the Formula Shortage.

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If you use powdered infant formula, be aware certain Similac, Alimentum and EleCare products have been recalled and should not be used.

The U.S. Food and Drug Administration (FDA) is investigating consumer complaints of bacterial infections in four infants who consumed powdered infant formula produced in Abbott Nutrition’s facility in Sturgis, Michigan. All four infants had to be hospitalized and the bacterial infection may have contributed to death in two patients.

The FDA has published a full list of recalled brands. Recalled products should no longer be available for sale. But if you have these products in your home, check the lot code on the bottom of the package to determine if they are included in the recall.

The FDA also is providing additional information for parents and caregivers of infants receiving medical specialty infant formula and individuals using certain medical foods.

Because infant formula is the only source of nutrition for many newborns and infants, the FDA understands and shares the concerns parents and caregivers may have.

Here’s information to help you as we continue our investigation.

What powdered infant formula products have been recalled?

Abbott Nutrition has recalled certain powdered infant formula products produced at its Sturgis, Michigan facility. Products from that facility can be found across the U.S. and some were exported to other countries. Here’s how you can tell if you have any of those products.

The FDA recommends consumers look at the lot code, a multidigit number on the bottom of a container of Similac, Alimentum and EleCare powdered infant formula and do not use if:

  • the first two digits of the code are 22 through 37; and 
  • the code on the container contains K8, SH or Z2; and 
  • the expiration date is 4-1-2022 (APR 2022) or later.

In addition to products described above, Abbott Nutrition has recalled Similac PM 60/40 with a lot code of 27032K80 (can) / 27032K800 (case).

You can also enter your product lot code on the company’s website to check if it is part of the recall. Please see the images below for a closer look at the identifying information.

Powdered Abbott products that don’t have the code and expiration noted above are not included in the recall. Liquid formula products are not subject to the recall. At this time, Similac PM 60/40 with lot code 27032K80 (can) / 27032K800 (case) are the only type and lots of this specialty formula being recalled. 

What infections have been reported and what symptoms should I look for?

All four cases involve Cronobacter sakazakii infection.

  • Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine). Cronobacter infections are rare but are especially high risk for newborns.
  • Symptoms related to Cronobacter infection include: poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.
  • If your infant is experiencing symptoms related to Cronobacter infection, contact your child’s health care provider to report his or her symptoms and receive immediate care.

When and where were the illnesses?

Illnesses occurred in Minnesota, Ohio, and Texas between September 6, 2021 and January 4, 2022.

I’m having a hard time finding formula. What is the FDA doing to help?

We are aware the recall has created new concerns about the availability of certain types of infant formula, particularly given the overall strains on supply chains experienced during the COVID-19 pandemic.

The FDA continues to take several significant actions to help increase the current supply of infant formula in the U.S. In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand.  

The FDA is working with Abbott Nutrition to better assess the impacts of the recall and understand the production capacity at other Abbott facilities that produce some of the impacted brands. We are also working with Abbott on safe resumption of production at the Sturgis, Michigan facility. As Abbott Nutrition was initiating its recall, the FDA intensified outreach to other infant formula manufacturers to inquire about their capacity and potential impacts. We will continue discussion with Abbott Nutrition and other infant formula manufacturers and consider all tools available to support the supply of infant formula products.

Are homemade formulas an alternative?

No. The FDA advises parents and caregivers not to make or feed homemade formula to infants. Homemade infant formula recipes have not been evaluated by the FDA and may lack nutrients vital to an infant’s growth.

What should I know about medical specialty infant formula and certain medical foods?

The Abbott Nutrition facility that produces recalled infant formulas also produces metabolic and other medical specialty infant formulas for infants with inborn errors of metabolism and other medical needs, as well as medical foods. These products, with the exception of one lot of Abbott Similac PM 60/40, have not been recalled because the FDA has determined that the risk of not having these specialty products available would significantly worsen underlying medical conditions. For many of these patients, the risk of life-threatening adverse events from restricted access to these critically needed products is likely greater than the risk from consuming products that have been produced at the facility. 

The FDA wants to be sure that parents and caregivers who use these specialty products are aware that there may be some risk of Cronobacter contamination. If possible, parents and caregivers should work with their medical provider to consider whether comparable products may be appropriate. If comparable alternative products are not available or appropriate, parents and caregivers should take extra care to follow the CDC’s updated advice for parents on how to reduce the risk of Cronobacter contamination of formula during preparation of powdered product, whether that contamination comes from the product itself or from other contamination sources in the home.  

Examples of medical and specialty products include Glutarex-1, Glutarex-2, Cyclinex-1, Cyclinex-2, Hominex-1, Hominex-2, I-Valex-1, I-Valex-2, Ketonex-1, Ketonex-2, Phenex-1, Phenex-2, Phenex-2 Vanilla, Pro-Phree, Propimex-1, Propimex-2, ProViMin, Calcilo XD, Tyrex-1, Tyrex-2, and Similac PM 60/40.

It is important to note that these specialty infant formulas and medical foods are not sold in traditional retail stores. These products often require a prescription and are sold through specialty pharmacies and other specialty distribution channels such as medical product suppliers.

Parents and caregivers of infants and children using these products should contact their child’s health care providers if they have questions about the use of these products.

Additionally, the FDA has informed Abbott Nutrition that the agency has no objection to the company immediately releasing product to individuals needing urgent, life-sustaining supplies of the specialty and metabolic formulas listed in the link below on a case-by-case basis. Abbott has confirmed with the FDA that the company will consider release of these products on a case-by-case basis, depending on product availability and the severity of the individual’s need. Patients and caregivers seeking access to these products should contact Abbott directly to request that a product be made available to them by calling 1-800-881-0876. For more information on those products, please see FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022).

What else should I know?

Parents and caregivers also should never dilute infant formula. Consumers also should avoid buying formula online that comes from outside the U.S., as it has the potential to be counterfeit.

If your regular formula is not available, contact your child’s health care provider for recommendations on changing feeding practices.

If you get infant formula through WIC, do not throw the formula out. Instead, you should take it to the store for a refund and exchange or call the company at 1-800-986-8540 to help you. WIC recipients should be able to obtain a different brand of similar formula. Call your local WIC clinic for more guidance.

Additional Resources:

  • Infant Formula: Safety Do’s and Don’ts, FDA Consumer Update
  • FDA Investigation of Cronobacter Infections: Powdered Infant Formula (February 2022), FDA webpage
  • Cronobacter Infection and Infants, CDC webpage

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