C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 7—ENFORCEMENT POLICY › Subpart C—Recalls (Including Product Corrections)—Guidance on Policy, Procedures, and Industry Responsibilities

21 C.F.R. § 7.46

Firm-initiated recall

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(a) A firm may decide of its own volition and under any circumstances to remove or correct a distributed product. A firm that does so because it believes the product to be violative is requested to notify immediately the appropriate Food and Drug Administration district office listed in § 5.115 of this chapter. Such removal or correction will be considered a recall only if the Food and Drug Administration regards the product as involving a violation that is subject to legal action, e.g., seizure. In such cases, the firm will be asked to provide the Food and Drug Administration the following information:

(1) Identity of the product involved.

(2) Reason for the removal or correction and the date and circumstances under which the product deficiency or possible deficiency was discovered.

(3) Evaluation of the risk associated with the deficiency or possible deficiency.

(4) Total amount of such products produced and/or the timespan of the production.

(5) Total amount of such products estimated to be in distribution channels.

(6) Distribution information, including the number of direct accounts and, where necessary, the identity of the direct accounts.

(7) A copy of the firm's recall communication if any has issued, or a proposed communication if none has issued.

(8) Proposed strategy for conducting the recall.

(9) Name and telephone number of the firm official who should be contacted concerning the recall.

(b) The Food and Drug Administration will review the information submitted, advise the firm of the assigned recall classification, recommend any appropriate changes in the firm's strategy for the recall, and advise the firm that its recall will be placed in the weekly FDA Enforcement Report. Pending this review, the firm need not delay initiation of its product removal or correction.

(c) A firm may decide to recall a product when informed by the Food and Drug Administration that the agency has determined that the product in question violates the law, but the agency has not specifically requested a recall. The firm's action also is considered a firm-initiated recall and is subject to paragraphs (a) and (b) of this section.

(d) A firm that initiates a removal or correction of its product which the firm believes is a market withdrawal should consult with the appropriate Food and Drug Administration district office when the reason for the removal or correction is not obvious or clearly understood but where it is apparent, e.g., because of complaints or adverse reactions regarding the product, that the product is deficient in some respect. In such cases, the Food and Drug Administration will assist the firm in determining the exact nature of the problem.

Notes of Decisions
Cited in 7 cases (2 in the last 5 years), 2012–2024 · leading case: Gross v. Stryker Corp., 858 F. Supp. 2d 466 (W.D. Pa. 2012).
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Gross v. Stryker Corp., 858 F. Supp. 2d 466 (W.D. Pa. 2012). “” 21 C.F.R. § 7.46 (emphasis added). Therefore, it is incorrect that "[b]y recalling the Trident System devices, Stryker admitted the [Trident System metal acetabular] cup was manufactured in violation of federal regulations and requirements.”
Wash. Cnty. Health Care Auth., Inc. v. Baxter Int'l Inc., 328 F. Supp. 3d 824 (E.D. Ill. 2018). “" 21 C.F.R. § 7.46 (a). A recall triggers an "evaluation of the health hazard presented by a product being recalled or considered for recall .”
Cline v. Advanced Neuromodulation Sys., Inc., 17 F. Supp. 3d 1275 (N.D. Ga. 2014). “21 C.F.R. § 7.46 (a). In turn, the FDA may classify a manufacturer’s action as a recall if the FDA “regards the product as involving a violation that is subject to legal action, e.”
Gates v. Medtronic, Inc., 192 F. Supp. 3d 704 (W.D. Tex. 2016). · cites it 3× “” 21 C.F.R. § 7.46 (a). When this occurs, the manufacturer must provide the FDA with the reasons for the device recall, the level of risk associated with the defect, the degree to which the defect has pervaded the marketplace, and most notably here, a copy of the firm’s recall…”
Alison Beavan v. Allergan U.S.A., Inc. (N.J. Super. Ct. App. Div. 2024). · cites it 3× “[ 21 C.F.R. § 7.46 .] However, any attempt to enforce or restrain violations of the FDCA "shall be by and in the name of the United States.”
Washington Cnty. Health Care Auth., Inc. v. Baxter Int'l Inc. (N.D. Ill. 2018). “” 21 C.F.R. § 7.46 (a). A recall triggers an “evaluation of the health hazard presented by a product being recalled or considered for recall .”
The Pictsweet Co. v. R.D. Offutt Co. (M.D. Tenn. 2021). “c) Failure to State a Claim The defendants move for dismissal of the TCPA claim insofar as it is premised upon the issuance of a recall, arguing that CRF’s voluntary recall is specifically authorized by federal regulation, 21 C.F.R. § 7.46 , and that the TCPA expressly provides…”
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