# 21 CFR § 107.210: Firm-initiated product removals

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-107.210

## Section

- **Citation:** 21 CFR § 107.210
- **Heading:** Firm-initiated product removals
- **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) If a manufacturer has determined to recall voluntarily from the market an infant formula that is not subject to § 107.200 but that otherwise violates the laws and regulations administered by the Food and Drug Administration (FDA) and that would be subject to legal action, the manufacturer, upon prompt notification to FDA, shall administer such voluntary recall consistent with the requirements of this subpart.
(b) If a manufacturer has determined to withdraw voluntarily from the market an infant formula that is adulterated or misbranded in only a minor way and that would not be subject to legal action, such removal from the market is deemed to be a market withdrawal, as defined in § 7.3(j) of this chapter. As required by § 107.240(a), the manufacturer shall promptly notify FDA of such violative formula and may, but is not required to, conduct such market withdrawal consistent with the requirements of this subpart pertaining to product recalls.

## 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-21-107.210. Check the current official text before relying on it. Not legal advice.