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Why are there drug recalls?


The Food and Drug Administration (FDA) recalls drugs as a way to protect the public. When an FDA-regulated product is defective or potentially harmful, it is recalled. FDA-regulated products may include human drugs, animal drugs, medical devices, radiation-emitting products, vaccines, blood blood products, transplantable human tissue, animal feed, cosmetics, and about 80% of the foods eaten in the United States.

Drug recall classes

Class I recalls are the most severe. It would be any dangerous or defective product that could cause serious health problems or death. Some examples include food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II recalls include products that might cause a temporary health problem or pose only a slight threat of a serious nature. Some examples include a drug that is under-strength but isn't used to treat a life-threatening situation.

Class III recalls include products that are unlikely to cause an adverse health reaction, but violate FDA labeling or manufacturing laws. Some examples include a minor container defect and lack of English labeling in a retail food. Often times the manufacturer does a voluntary recall of their product even if the FDA does not mandate it.

For the latest product and drug recall notices, please visit

Back to Ask a Pharmacist


Answers to questions regarding information about medications or health conditions are not for diagnostic or treatment purposes and are not conclusive as to the presence or absence of any health condition. Consult your physician for diagnosis and treatment of your medical condition. The information provided is not a substitute for medical advice. Advances in medicine may cause this information to become outdated, invalid or subject to debate. Professional opinions and interpretations of the scientific literature may vary. Walgreens' terms of use and general warranty disclaimer apply to all services provided. If you are in need of immediate medical attention, contact your physician, poison control center or emergency medical professional. If you need to speak with a pharmacist for non-emergency matters, contact your local Walgreens pharmacist or call a pharmacist toll-free at 1 (877) 250-5823.

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