Drug Safety Alerts

Abbott PediaSure Harvest and Ensure Harvest Consumer-Level Recall

8/10/2022

On August 10, 2022, Abbott issued consumer-level recall of PediaSure Harvest and Ensure Harvest. This recall was issued due to the potential for microbial contamination, including from the organisms Cronobacter sakazakii and Clostridium botulinum.

This may represent a potential health hazard or safety risk to plan members using products affected by this recall.

A list of the affected products and lot #s is provided at the end of this here.

Although Abbott has stated that Clostridium botulinum has not been found in products, consumers are warned not to consume any of the recalled products even if they do not look or smell spoiled.

While infection related to Cronobacter sakazakii is rare, the common symptoms of illness could include fever, vomiting and urinary tract infection. However, vulnerable and immunocompromised populations may be susceptible to more severe symptoms.

Clostridium botulinum may cause a severe form of food poisoning. It can begin from six hours to two weeks after eating food that contains the toxin. Symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, and weak muscles. Botulism poisoning can cause respiratory paralysis, resulting in death, unless assistance with breathing (mechanical ventilation) is provided. People experiencing these problems should immediate medical attention.

Abbott recommends that consumers should not consume product that is affected by this recall.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, call Abbott at 1-877-745-8237. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.