FDA 101: Product Recalls
FDA evaluates whether all reasonable efforts have been made to remove or correct a product. A recall is considered complete after all of the company's corrective actions are reviewed by FDA and deemed appropriate. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned, and investigates why the product was defective in the first place.
These guidelines categorize all recalls into one of three classes, according to the level of hazard involved:
Class I: Dangerous or defective products that predictably could cause serious health problems or death. 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: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.
Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.
FDA-regulated Products Subject to Recall
- human drugs
- animal drugs
- medical devices
- radiation-emitting products
- blood and blood products
- transplantable human tissue
- animal feed
- about 80 percent of the foods eaten in the United States
For more information about topics for your health, visit the FDA Consumer Information Center (www.fda.gov/consumer).
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