Who can initiate a drug recall?

• A. The FDA only
• B. The drug manufacturer or the FDA
• C. State boards of pharmacy only
• D. Patients

Answer: (B)

The ability to initiate a drug recall rests with both the manufacturer and the regulatory agency. A drug manufacturer can voluntarily recall a product when it identifies a safety issue, taking action to remove or correct the product from the market. The FDA also has authority to require or request a recall when a safety problem is found or reported, using regulatory powers under the FD&C Act and evaluating recalls by class I, II, or III risk. State boards of pharmacy regulate practice and may coordinate actions, but they do not initiate recalls themselves. Patients can report adverse events, but they do not have the authority to start a formal recall.