# 21 C.F.R. § 107.260 (2026): Revision of an infant formula recall

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_260

## Section

- **Citation:** 21 C.F.R. § 107.260 (2026)
- **Heading:** Revision of an infant formula recall
- **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 / § 107.260: § 107.260   Revision of an infant formula recall.

## Text

If after a review of the recalling firm's recall strategy or periodic reports or other monitoring of the recall, the Food and Drug Administration concludes that the actions of the recalling firm are deficient, the agency shall notify the recalling firm of any serious deficiency. The agency may require the firm to:
(a) Change the extent of the recall, if the agency concludes on the basis of available data that the depth of the recall is not adequate in light of the risk to human health presented by the infant formula.
(b) Carry out additional effectiveness checks, if the agency's audits, or other information, demonstrate that the recall has not been effective.
(c) Issue additional notifications to the firm's direct accounts, if the agency's audits, or other information demonstrate that the original notifications were not received, or were disregarded in a significant number of cases.

## 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)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_260. Check the current official text before relying on it. Not legal advice.