Voluntary and mandatory recalls, and where FDA's power stops

Of the 18,076 drug recall records in FDA's enforcement database since June 2012, 18,012 carry the label "Voluntary: Firm initiated." Twenty-nine are marked "FDA Mandated," and all 29 come from two recall events posted in 2019. The rest have the field blank or marked not applicable. Those figures come from GxRadar's analysis of the openFDA drug enforcement data¹ through Oct. 28, 2026.

FDA's openFDA field reference² explains the imbalance in one line: "Recalls are almost always voluntary, meaning initiated by a firm." It also notes that a recall counts as voluntary even when FDA asked for it.

For most drugs, that is the law. FDA can order recalls of medical devices, foods, tobacco, infant formula, licensed biological products, cosmetics and controlled substances. For an ordinary prescription or over-the-counter drug that is not a controlled substance, including most generics, it can ask, and if a firm says no it can go to court. This piece walks through the regulation, the products where FDA does hold order authority, and the bills that would extend it to all drugs.

What Part 7 says about voluntary recalls

FDA's general recall rules sit in 21 CFR part 7, subpart C. The policy section opens with a statement of principle: "Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health," 21 CFR 7.40³ says. The same section calls recall "an alternative to a Food and Drug Administration-initiated court action."

There are two voluntary routes. In a firm-initiated recall under 21 CFR 7.46⁵, a company decides on its own to remove or correct a product and is asked to notify FDA immediately, with details on the product, the problem, the amount in distribution and its proposed recall communication. FDA's drug recalls page⁷ describes the result the same way: "A recall is a voluntary action taken by a company."

In an FDA-requested recall under 21 CFR 7.45⁴, the commissioner or a designee asks a firm to recall a product after finding that it "presents a risk of illness or injury or gross consumer deception," that the firm has not acted, and that agency action is needed. Section 7.40 says such requests are "reserved for urgent situations." FDA's Regulatory Procedures Manual⁸ adds that requested recalls "are most often classified as Class I" and that before making one, the agency will generally have evidence capable of supporting a seizure, injunction or warning letter.

FDA's 2022 guidance on initiating voluntary recalls⁹ covers the practical side, including the recall procedures firms are expected to have ready before a problem appears. GxRadar's explainer on how drug recalls work follows a recall from start to finish.

Where FDA can order a recall

Congress has given FDA order authority product by product. FDA's recall procedures manual⁸ lists these as "ordered recalls" and "mandated recall requirements," and FDA's recall definitions page⁶ notes that recalls may happen "by FDA order under statutory authority."

Sources: 21 U.S.C. 360h¹⁰, 21 U.S.C. 387h¹¹, 21 U.S.C. 350l¹², 21 U.S.C. 360bbb-8d¹³, 21 U.S.C. 364g¹⁴ and 42 U.S.C. 262¹⁵, via the Legal Information Institute; FDA Regulatory Procedures Manual, Chapter 7. The manual also lists infant formula and human tissue products, which have their own mandated recall rules.

Device, tobacco, controlled-substance and cosmetics provisions follow a similar pattern. FDA issues an order to stop distribution, the firm gets an informal hearing within 10 days (two days for food), and FDA then vacates the order, keeps it in place or amends it to require a recall. The controlled-substance provision, added by the 2018 SUPPORT for Patients and Communities Act, adds a twist: if FDA finds that recalling a drug "presents a greater health risk than the health risk of not recalling," the amended order may not require a recall or a halt to distribution, according to the statute's text¹³.

The biologics provision is the bluntest. If a lot of a licensed biological product "presents an imminent or substantial hazard to the public health," 42 U.S.C. 262(d)¹⁵ directs FDA to order its immediate recall, with civil penalties of up to $100,000 a day for violations, a figure the statute raises each year with the Consumer Price Index. Biosimilars are licensed under the same section, a distinction covered in how biosimilars differ from generics.

What FDA can do when a drug firm refuses

For a generic tablet approved under an abbreviated new drug application, and not a controlled substance, FDA's leverage is the courts. Under 21 U.S.C. 334¹⁶, an adulterated or misbranded drug in interstate commerce is "liable to be proceeded against" and condemned in federal district court. Under 21 U.S.C. 332¹⁷, district courts can restrain violations of the act. Section 7.40 says seizure or other court action is indicated when a firm refuses a requested recall, or when FDA believes a recall would not work or finds that a violation is continuing.

Court orders can also produce recalls. The procedures manual⁸ says recalls may be ordered under the terms of a consent decree when FDA finds that the defendants have not complied, and that consent decrees "typically authorize FDA to bill defendants" for the cost of monitoring. The openFDA records do not say which legal basis lay behind the 29 drug records marked "FDA Mandated" in 2019. Our pieces on inspections and warning letters and CGMP describe the steps that usually come first.

The bills that would extend order authority to all drugs

Members of Congress have tried for years to give FDA the same tool for all drugs. The Recall Unsafe Drugs Act of 2020, H.R. 5578¹⁸, introduced Jan. 10, 2020, would have let FDA order any person distributing a drug to cease distribution when it had reason to believe the drug "may cause serious adverse health consequences or death." A 2023 version, H.R. 3688¹⁹, followed on May 25, 2023. A separate approach, in H.R. 2500²⁰ of April 6, 2023, would simply have extended the 2018 controlled-substance authority to every drug.

The latest is H.R. 7980²¹, the Protecting Americans from Unsafe Drugs Act of 2026, introduced March 18, 2026, and referred to the House Energy and Commerce Committee. It takes the short route. It would amend section 569D by striking "controlled substance" each place it appears and inserting "drug."

None of the earlier bills became law, and the published text of 21 U.S.C. 360bbb-8d¹³ still covers only controlled substances. Until that changes, a drug recall in FDA's records will almost always read "Voluntary: Firm initiated." The current list of drug recalls, by class and reason, is on GxRadar's recall page, and our guide to market withdrawals and safety alerts covers the removals that fall outside the recall definition.