06.04.2022 UPDATE: Abbott Nutrition has resumed baby formula production at its Sturgis, Michigan, plant, in a move to address a nationwide shortage.
The company said it will restart the production of EleCare, a formula for children with digestive issues, aiming for an initial product release around June 20.
05.24.2022 UPDATE: Abbott To Release Elecare® Amino Acid-Based Formulas to Help Meet Critical Patient Need
05.13.2022 UPDATE: Abbott Provides Infant Formula Update
05.05.2022 UPDATE: At the request of U.S. Food and Drug Administration (FDA), Abbott is releasing limited quantities of metabolic and Similac PM 60/40 nutrition formulas that were previously on hold following Abbott’s recall of some powder formulas from its Sturgis, Michigan facility.
The products being released:
- have been tested
- were not a part of the recall, and
- comply with all product release requirements before distribution.
Abbott has limited quantities of these formulas available. They will be released on a case-by-case basis, prioritizing patients whose healthcare professional teams have determined are an urgent need.
Abbott is releasing this product at no charge to patients. Patients will need to work directly with their healthcare professional to obtain this formula. Patients will need a physician order.
Shield HealthCare will not be receiving or distributing this limited-release formula. The formula will be released directly to physicians. Please contact your physician for more information.
Please contact Abbott Consumer Relations at 1-800-881-0876 with any questions.
02.28.2022 UPDATE: Abbott is additionally recalling one lot of Similac PM 60/40 (Lot # 27032K80 (can) / Lot # 27032K800 (case)) manufactured in Sturgis, Michigan. This is in addition to lots of Similac®, Alimentum® and EleCare® powder formula that were voluntarily recalled on Feb. 17.
Similac PM 60/40 is intended for infants who need a lower mineral intake. Abbott added a specific lot of this product to the recall after an infant who consumed it died after testing positive for Cronobacter sakazakii. This is the second reported fatal case linked to powdered baby formula since September. An investigation is ongoing.
Abbott Nutrition, the formula manufacturer which makes Similac, Alimentum and EleCare, has issued a voluntary recall of specific lot numbers of their powdered formulas. This recall came after receiving four complaints of babies hospitalized with bacterial infections, including one death. The Abbott Nutrition facility which manufactured the recalled formulas is located in Sturgis, Michigan.
The recalled formulas must meet the following criteria:
- The first two digits of the lot code, printed near the expiration date, are between 22 and 37
- The lot code also contains K8, SH or Z2
- The expiration date is April 2022 or later
What Bacteria are Involved in the Complaints?
Of the four complaints, three involve Cronobacter sakazakii infections and one involves a salmonella infection, all of which required hospitalization. Cronobacter may have contributed to a death in one case. Cronobacter infections are rare but can be especially dangerous for newborn babies. Symptoms of a Cronobacter infection include: poor feeding, irritability, temperature changes, jaundice, grunting breaths and abnormal movements. Cronobacter bacteria can cause life-threatening infections (sepsis) or meningitis. Symptoms of a salmonella infection include: fever, diarrhea and abdominal cramps. More severe salmonella symptoms may include high fever, aches, headaches, lethargy, rash, or blood in the urine or stool. In rare cases, salmonella may become fatal.
How is a Voluntary Recall Different From a Mandatory Recall?
In the United States, the government can initiate a product recall. A government-requested recall is mandatory. However, companies also have the power to initiate a product recall. These recalls are referred to as “voluntary recalls” because the company voluntarily took action without having been told to do so by the government.
When it comes to food safety recalls, “voluntary” does not mean optional, and it does not mean unnecessary. Regardless of whether the recall is initiated by the U.S. government or by the company, a recall means the product is unsafe and appropriate action must be taken.
The Code of Federal Regulations (21 CFR 7) states: “Recall means a firm’s removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action.” This means that regardless of whether a recall is “voluntary” or “mandatory,” the food is considered unsafe and thus violates the law.
What Brands are Affected?
Abbott Nutrition is recalling specific lots of Similac, Alimentum and EleCare powder formulas. The list of brands include (but are not limited to):
- Alimentum
- Alimentum Advance
- Elecare Infant
- Elecare Junior
- Similac Sensitive
- Similac Advance
- Similac Organic
- Similac Human Milk Fortifier
- Similac Pro-Sensitive
- Similac Pro-Advance
- Similac Spit Up
- Similac Sensitive Spit Up
- Similac Total Comfort
- Similac PM 60/40 – added to recall on 2/28/22
Abbott Nutrition is emphasizing that no distributed product has tested positive for either bacteria involved in the complaints: Cronobacter sakazakii or Salmonella Newport bacteria. During testing in the Sturgis, Michigan facility, evidence of Cronobacter sakazakii was found in the plant in non-product contact areas. No evidence of Salmonella Newport has been discovered. Only product manufactured at the Sturgis, Michigan facility is involved in this recall.
Is Liquid Formula Also Being Recalled?
No Abbott liquid formulas are impacted by this recall. This recall also does not include any metabolic deficience nutrition formulas.
Where Do I Check If My Cans Have Been Recalled?
To find out if your product is included in this recall, visit similacrecall.com and type in the code on the bottom of the package, or call 800-986-8540 (U.S.) and follow the instructions provided.
If you have questions about feeding your child, please contact your child’s healthcare team. If your child is experiencing any symptoms of a Cronobacter or salmonella infection, you should notify your child’s healthcare provider and seek medical care for your child immediately.
The products being recalled have a multidigit number on the bottom of the container which:
- Begins with the first two digits between 22 and 37
- Contains K8, SH, or Z2
- Has an expiration date of April 1, 2022 or later.
Can I Get a Refund or Replacement for Recalled Formula?
If your formula is impacted by the recall, you should throw it away. You can visit SimilacRecall.com for a refund or a replacement.
No matter what formula you use, you should always follow the Centers for Disease Control and Prevention’s instructions for proper preparation, handling and storage. This includes washing your hands before preparing formula, and using prepared formula within one hour from when feeding starts.
Sources:
- www.fda.gov/news-events/press-announcements/fda-warns-consumers-not-use-certain-powdered-infant-formula-produced-abbott-nutritions-facility
- www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-and-salmonella-complaints-powdered-infant-formula-february-2022
- www.fda.gov/food/resources-you-food/industry-and-consumer-assistance-cfsan
- www.cnet.com/health/parenting/formula-recall-check-if-your-abbott-baby-formula-is-safe-heres-how/
- www.npr.org/2022/02/18/1081697742/stop-using-these-baby-formulas-the-fda-says-after-4-infants-are-hospitalized
- www.qualityassurancemag.com/article/voluntary-recalls-are-not-optional/
