# 21 C.F.R. § 107.240 (2026): Notification requirements

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P107_S107_240

## Section

- **Citation:** 21 C.F.R. § 107.240 (2026)
- **Heading:** Notification requirements
- **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 / § 107.240: § 107.240   Notification requirements.

## Text

(a)
Telephone report.
When a determination is made that an infant formula is to be recalled, the recalling firm shall telephone within 24 hours the appropriate Food and Drug Administration district office listed in § 5.115 of this chapter and shall provide relevant information about the infant formula that is to be recalled.
(b)
Initial written report.
Within 14 days after the recall has begun, the recalling firm shall provide a written report to the appropriate FDA district office. The report shall contain relevant information, including the following cumulative information concerning the infant formula that is being recalled:
(1) Number of consignees notified of the recall and date and method of notification, including recalls required by § 107.200, information about the notice provided for retail display, and the request for its display.
(2) Number of consignees responding to the recall communication and quantity of recalled infant formula on hand at each consignee at the time the communication was received.
(3) Quantity of recalled infant formula returned or corrected by each consignee contacted and the quantity of recalled infant formula accounted for.
(4) Number and results of effectiveness checks that were made.
(5) Estimated timeframes for completion of the recall.
(c)
Status reports.
The recalling firm shall submit to the appropriate FDA district office a written status report on the recall at least every 14 days until the recall is terminated. The status report shall describe the steps taken by the recalling firm to carry out the recall since the last report and the results of these steps.
[79 FR 8074, Feb. 10, 2014]

## 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_240. Check the current official text before relying on it. Not legal advice.