# 21 C.F.R. § 107.220 (2026): Scope and effect of infant formula recalls

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_220

## Section

- **Citation:** 21 C.F.R. § 107.220 (2026)
- **Heading:** Scope and effect of infant formula recalls
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 107: INFANT FORMULA / Subpart E: Infant Formula Recalls / § 107.220: § 107.220   Scope and effect of infant formula recalls.

## Text

(a) The requirements of this subpart apply:
(1) When the Food and Drug Administration has determined that it is necessary to remove from the market a distributed infant formula that is in violation of the laws and regulations administered by the Food and Drug Administration and that poses a risk to human health; or
(2) When a manufacturer has determined that it is necessary to remove from the market a distributed infant formula that:
(i) Is no longer subject to the manufacturer's control;
(ii) Is in violation of the laws and regulations administered by the Food and Drug Administration and against which the agency could initiate legal or regulatory action; and
(iii) Does not present a human risk.
(b) The Food and Drug Administration will monitor continually the recall action and will take appropriate actions to ensure that the violative infant formula is removed from the market.

## Nearby sections

- [21 C.F.R. § 107.200 (2026) § 107.200   Food and Drug Administration-required recall.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_200.md)
- [21 C.F.R. § 107.210 (2026) § 107.210   Firm-initiated product removals.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_210.md)
- [21 C.F.R. § 107.220 (2026) § 107.220   Scope and effect of infant formula recalls.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_220.md)
- [21 C.F.R. § 107.230 (2026) § 107.230   Elements of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_230.md)
- [21 C.F.R. § 107.240 (2026) § 107.240   Notification requirements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_240.md)
- [21 C.F.R. § 107.250 (2026) § 107.250   Termination of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_250.md)
- [21 C.F.R. § 107.260 (2026) § 107.260   Revision of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_260.md)
- [21 C.F.R. § 107.270 (2026) § 107.270   Compliance with this subpart.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_270.md)
- [21 C.F.R. § 107.280 (2026) § 107.280   Records retention.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_280.md)

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_220. Check the current official text before relying on it. Not legal advice.