# 21 CFR § 107.220: Scope and effect of infant formula recalls

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-107.220

## Section

- **Citation:** 21 CFR § 107.220
- **Heading:** Scope and effect of infant formula recalls
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION > PART 107—INFANT FORMULA > Subpart E—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 CFR § 107.1 § 107.1 Status and applicability of the regulations in part 107.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.1.md)
- [21 CFR § 107.3 § 107.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.3.md)
- [21 CFR § 107.10 § 107.10 Nutrient information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.10.md)
- [21 CFR § 107.20 § 107.20 Directions for use.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.20.md)
- [21 CFR § 107.30 § 107.30 Exemptions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.30.md)
- [21 CFR § 107.50 § 107.50 Terms and conditions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.50.md)
- [21 CFR § 107.100 § 107.100 Nutrient specifications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.100.md)
- [21 CFR § 107.200 § 107.200 Food and Drug Administration-required recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.200.md)
- [21 CFR § 107.210 § 107.210 Firm-initiated product removals.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.210.md)
- [21 CFR § 107.220 § 107.220 Scope and effect of infant formula recalls.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.220.md)
- [21 CFR § 107.230 § 107.230 Elements of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.230.md)
- [21 CFR § 107.240 § 107.240 Notification requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.240.md)
- [21 CFR § 107.250 § 107.250 Termination of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.250.md)
- [21 CFR § 107.260 § 107.260 Revision of an infant formula recall.](https://www.frixlaw.com/law-library/statutes/ecfr-21-107.260.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-107.220. Check the current official text before relying on it. Not legal advice.