The Food and Drug Administration announced two Class I recalls, the agency’s highest hazard level, affecting broccoli sprouts distributed to multiple states and a nationwide recall of epinephrine injection vials used to treat severe allergic reactions, on Sept. 11.
Evergreen Fresh Sprouts LLC is recalling broccoli sprouts due to potential contamination with Salmonella, a bacteria capable of causing serious illness, particularly in children, elderly individuals, and immunocompromised consumers, the FDA said.
In a separate action, American Regent issued a nationwide recall of epinephrine injection vials due to the confirmed presence of particulate matter and sterility concerns. Epinephrine is a critical emergency medication used to treat anaphylaxis, severe and life-threatening allergic reactions to foods, insect stings, medications, and other triggers.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death, according to the FDA’s classification system. The designation is reserved for the most dangerous product defects.
The epinephrine recall is particularly significant given that the drug has no substitute in the emergency treatment of anaphylaxis. Compromised vials in emergency kits, schools, ambulances, or hospital crash carts could fail to deliver the life-saving medication when needed, or the particulate matter could cause additional harm when injected.
Americans with severe allergies, parents of children with food allergies, school nurses, and emergency medical technicians should check lot numbers on their epinephrine supplies against the recall notice posted on the FDA’s website, the agency said.
Salmonella infections from contaminated produce cause an estimated 1.35 million infections in the United States annually, according to the Centers for Disease Control and Prevention. Sprouts are particularly susceptible to bacterial contamination because the warm, humid conditions required for sprouting also promote bacterial growth.
The FDA urged consumers who have purchased the recalled broccoli sprouts to discard them immediately and contact their health care provider if they experience symptoms of Salmonella infection.
American Regent said it is working with the FDA to notify health care providers and distributors about the epinephrine recall.