21 CFR § 107.200 - Food and Drug Administration-required recall.

---
identifier: "/us/cfr/t21/s107.200"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 107.200 - Food and Drug Administration-required recall."
title_number: 21
title_name: "Food and Drugs"
section_number: "107.200"
section_name: "Food and Drug Administration-required recall."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "107"
part_name: "INFANT FORMULA"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 343, 350a, 371."
regulatory_source: "50 FR 1840, Jan. 14, 1985, unless otherwise noted."
cfr_part: "107"
---


# 107.200 Food and Drug Administration-required recall.

When the Food and Drug Administration determines that an adulterated or misbranded infant formula presents a risk to human health, a manufacturer shall immediately take all actions necessary to recall that formula, extending to and including the retail level, consistent with the requirements of this subpart.