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FDA 101: Product Recalls

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Alerting the Public continued...

"It's about being as transparent as possible," says Catherine McDermott, public affairs manager in the Division of Federal-State Relations in FDA's Office of Regulatory Affairs. "If we feel there is that much of a health risk, we will offer media updates every day to give new information, and all that we know gets posted to FDA's Web site."

Not all recalls are announced in the media. But all recalls go into FDA's weekly Enforcement Report. This document lists each recall according to classification (see "Recall Classifications" box), with the specific action taken by the recalling firm.

Effectiveness Checks

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.

Recall Classifications

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
  • vaccines
  • blood and blood products
  • transplantable human tissue
  • animal feed
  • cosmetics
  • 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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