Glossary: Recalls and Alerts

A recall is an action taken by a pharmaceutical manufacturer or distributor to remove a product from the market. In most cases, companies initiate a voluntary recall after discovering potential problems that are in violation of the law. In other cases, the FDA recognizes the problem and requests that the company recall the product. If the company does not comply, the FDA may pursue regulatory action to have the product seized.

Recalls may occur at the consumer, retail or wholesale level. 

• Consumer-level recall: Includes individual patients, physicians and hospitals and may require action on the part of the consumer, such as returning for a medication to the pharmacy for a refund or calling a special hotline number for more information. 
• Retail-level recalls: Directed at retailers and providers. 
• Wholesale-level recalls: Involves distribution between the manufacturer and retailer.

• Class I: The most serious, class I recalls are issued when there is a defect with a drug – due to contamination of raw materials, for example – or labeling that could lead to serious health problems or even death.
• Class II: Class II recalls are issued when exposure to the drug may cause a temporary or medically reversible health problem or a slight chance of a serious problem.
• Class III: Class III recalls are issued for products that violate FDA regulations – for example, a bottle that doesn’t contain the number of pills stated on the label – but are unlikely to cause adverse health consequences.

Market withdrawal: A market withdrawal is an action taken by a manufacturer to remove or correct a distributed product due to a minor violation that would not be subject to legal action by the FDA.

Medical device safety alert: An alert issued by the manufacturer of a medical device that presents a risk of substantial harm. These are sometimes considered recalls.

Black box warning: Also called a “boxed warning,” this an alert the FDA may require manufacturers to place on a medication label or package insert if medical studies suggest the drug carries a significant risk of serious or life-threatening adverse events.

Drug shortage: Defined by the FDA as a situation in which the total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the patient level.

• Recalls.gov – www.recalls.gov
• MedWatch; The FDA Safety Information and Adverse Event Reporting Program – www.fda.gov/MedWatch/report.htm, 800/332-1088
• FDA Recalls, Market Withdrawals, and Safety Alerts – www.fda.gov/Safety/Recalls/default.htm
• FDA Enforcement Reports – www.fda.gov/Safety/Recalls/EnforcementReports/default.htm