FD&C Act Section 421 - Mandatory Recall Authority

What it says

Section 421 gives FDA authority to order a responsible party to cease distribution and recall an article of food, other than infant formula, if FDA determines there is a reasonable probability that the food is adulterated or misbranded in certain ways and that its use or exposure will cause serious adverse health consequences or death. FDA first gives the party an opportunity to recall voluntarily, and the party can request an informal hearing.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Most recalls are voluntary, and the order is a backstop when a firm does not act.
• A firm should be ready to act fast, with a recall plan and traceability records.
• FDA can use the authority for food from any registered facility.

What FDA inspectors look for

• Whether a recall plan exists and works.
• Whether product can be traced to customers quickly.
• Whether the firm acts promptly when a problem is found.

Related regulations