How drug recalls end

On Oct. 28, 2026, FDA's public file of drug recalls held 18,076 product records going back to mid-2012. An openFDA count by status¹ shows 14,814 of them marked terminated, 2,824 ongoing and 438 completed. Of the ongoing records, 231 are Class I, the category for products with a reasonable probability of causing serious harm or death, according to an openFDA search of open Class I records¹.

News coverage of a recall usually stops at the announcement. The paperwork runs much longer. A recall closes only when FDA decides the product has been pulled back or fixed, and that decision follows rules in federal regulations and in the agency's internal procedures manual.

Anyone who looks up a recall months after it began needs the status label, because it shows whether FDA still treats the problem as live. GxRadar used the openFDA drug enforcement data¹ to measure how long recalls stay open, and read the rules that decide when they close. A typical recall event took about 16 and a half months to reach termination. Class I recalls took longer. And the number of terminations recorded in the file has fallen sharply since 2024.

Three statuses, defined by FDA

FDA's Enforcement Report definitions² use three labels. An ongoing recall is "a recall which is currently in progress." A recall is completed when "the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections." Termination comes later, and it is FDA's call.

Federal regulations spell out the termination standard in 21 CFR 7.55⁴. A recall "will be terminated when the Food and Drug Administration determines that all reasonable efforts have been made to remove or correct the product in accordance with the recall strategy," and when it is reasonable to assume the product has been removed and properly disposed of or corrected "commensurate with the degree of hazard." FDA then sends the recalling firm written notice. A firm may also ask for termination in writing, attaching its latest status report and a description of what happened to the recalled stock.

Source: openFDA drug enforcement API, status and classification searches. One ongoing record had not yet been classified. Each record is one product, and a single recall event can include hundreds of them.

Effectiveness checks come before the end

Before a recall can close, someone has to confirm the warning reached the people holding the product. Under 21 CFR 7.42⁵, every recall strategy sets a depth (wholesale, retail, or consumer and user level) and a level of effectiveness checks. Their stated purpose is "to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action." A consignee, in the Part 7 definitions⁷, is "anyone who received, purchased, or used the product being recalled."

Source: 21 CFR 7.42(b)(3).

Recalling firms normally run these checks by letter, phone call or visit. FDA runs its own spot checks as well. Chapter 7 of FDA's Regulatory Procedures Manual³ (the July 2021 version posted on the agency's site) calls them recall audit checks, meant "to determine if a recalling firm's consignees received notification of the recall, and followed the instructions listed in the notification." The manual says audit checks "are not normally performed for Class III recalls."

Firms also file progress reports. 21 CFR 7.53⁶ leaves the schedule to FDA in each case but says "generally the reporting interval will be between 2 and 4 weeks." Each report lists how many consignees were notified, how many responded and how many did not, how much product came back, and the results of effectiveness checks.

Who signs off

Who signs depends on the hazard. Under the procedures manual, "Class II and III recalls and market withdrawals may be terminated at the division's discretion," while "termination of a Class I recall requires center concurrence," meaning approval from the FDA center that oversees drugs. Before recommending termination, a division reviews audit check results, the firm's status reports and records showing what was done with the product. For Class I and high-risk Class II recalls, an investigator may make a "limited close-out inspection" to watch recalled stock being destroyed or reworked.

FDA's manual also sets a pace. "FDA should terminate the recall within three months after the firm completes the recall," it says, and division offices "should not wait for compliance actions to be initiated or executed to terminate a recall."

Records in the completed bucket suggest that timetable often slips. None of the 438 completed records was first reported in 2026, and 165 of them first appeared in Enforcement Reports in 2019. The file does not record the date a firm finished its recall, so GxRadar cannot say exactly how long each one has waited.

How long recalls stay open

Building on its count of recall records and events, GxRadar measured the time from each recall event's initiation date to its termination date, using the latest termination among the event's product records. The 3,654 fully terminated events with dates had a median of 504 days. Each event is placed in the most serious class among its records.

Source: GxRadar analysis of openFDA drug enforcement records through Oct. 28, 2026.

These figures understate how long recalls really last, because events that are still open are left out. Seventy-one events with records started before 2021 are still listed as ongoing, including two from 2012. The oldest is a Class I recall of a tablet sold as a sexual enhancement product, started in March 2012.

Terminations have slowed since 2024

An openFDA count by termination date¹ shows 1,672 drug recall records terminated in 2023 and 1,338 in 2024. The figure dropped to 625 in 2025 and to 146 in 2026 through Oct. 28. New recalls did not fall off in the same way, as GxRadar's recall charts show.

Source: openFDA drug enforcement API, counts by report date and termination date.

As a result, the open pile grew. Of the 2,824 ongoing records, 1,349 have recall start dates in 2025 or 2026, according to an openFDA count of ongoing records by start date¹. The data do not explain the slowdown. Terminations arrive in bursts (297 records were closed in March 2025 and 91 in February 2026), and status fields can be updated late, so some of the gap may be filled in later.

What the label tells a reader

A terminated recall does not certify that every affected package was found. The regulatory test is "all reasonable efforts" plus a reasonable assumption that the product is gone, scaled to the hazard. The openFDA documentation¹ describes FDA's job in every recall as overseeing the company's strategy, classifying the products and assessing "the adequacy of the recall." FDA's recall definitions page⁸ notes that recalls may happen "on a firm's own initiative, by FDA request, or by FDA order." Someone who finds a recalled lot number at home after the recall has closed can still ask a pharmacist what to do with it; FDA's general options are covered in how to dispose of unused medicines.

An ongoing label, for its part, often reflects paperwork more than danger in the supply chain. The record will not show whether the product is still on shelves. Our guides on checking whether a medicine was recalled and reading a recall notice explain the lot fields, and How drug recalls work covers the front end of the process. For what lands in the most serious class, see What FDA's Class I drug recall records show.

FDA's openFDA service updates the enforcement file weekly, and the GxRadar feed picks up each new Enforcement Report. The next sign of whether terminations are catching up will be the count of 2025 recalls still marked ongoing at the end of this year, which stood at 690 records on Oct. 28.