Can the FDA issue a recall for medications?

The FDA does not have the authority to unilaterally enforce a recall of medications; instead, they can only request recalls. The agency can issue a formal request for a manufacturer to voluntarily recall a product if it is found to be unsafe, misbranded, or in violation of regulations. The actual decision to recall rests with the manufacturer, who assesses the situation and determines the best course of action.

Class I recalls involve products that could cause serious harm or death, making them a top priority for the FDA's attention and recommendations. However, the FDA’s ability to enforce recalls is typically limited to promoting voluntary compliance, which is why it's accurate to assert that they can only request it.

The distinctions between Classes of recalls (I, II, and III) are important in the context of safety and risk, but they do not alter the fundamental nature of the FDA's role in initiating a recall. Thus, the correct understanding of the FDA's authority reflects its position as an agency that guides and advises rather than one that actively enforces recalls on its own.