How to check drug recalls on the FDA list of recalled drugs
The full list of US drug recalls is the FDA weekly Enforcement Report. How to search it, what recall classes mean, and how recalls differ from withdrawals.
How to check drug recalls on the FDA list
To check US drug recalls, search the weekly Enforcement Report by product type "Drugs". That is the FDA drug recalls list. It covers the recalls FDA monitors, with class (I, II, III or not yet classified), reason, firm, lot codes and status. FDA's public notices page shows only recalls with press releases or other public notices, so it is a partial list.
Where to find the list of drug recalls
FDA runs three public sources for drug recalls. They overlap, but they are not the same list.
| Source | What it holds | Complete? |
|---|---|---|
| Enforcement Report search | Recalls FDA monitors, classified or not yet classified, from June 8, 2012 | Yes, subject to reporting delays |
| Recalls, Market Withdrawals, & Safety Alerts | Recalls with a press release or other public notice | No |
| CDER Drug Recalls | Drug recall announcements by company, downloadable as XLSX | No |
FDA says on the recalls page: "Not all recalls have press releases or are posted on this page." Press releases go out for recalls "that may potentially present a significant or serious risk to the consumer or user of the product," and that posting is separate from the classification process. A recall's class alone does not tell you whether it appears on the public notices page.
How to search the FDA Enforcement Report
Open the Enforcement Report search and set Product Type to Drugs. You can then filter by product description, recalling firm, recall number, event ID, code information (lot numbers), recall class, status, reason for recall, and a classified from/to date. Export the results to CSV if you need a medication recall list of your own.
Since June 15, 2017 the report also lists recalls FDA has not yet classified. A firm notice "may occur well before the FDA completes its classification process." Since July 24, 2018 the report tracks later changes to the classification, reason for recall, code information and product description, so an entry can change after you first see it. FDA may also delay publishing some drug recalls under 21 CFR 7.50. Check the firm's notice when timing matters.
For bulk work, the openFDA drug enforcement API returns drug recall records from FDA's Recall Enterprise System, updated weekly. Its fields include recall_number, classification, status, code_info, reason_for_recall, distribution_pattern, voluntary_mandated and termination_date. The API metadata checked on October 10, 2026 showed a last update of September 30. That snapshot may miss newer recalls. Weekly updates are not same-day alerts.
What the recall classes mean
FDA assigns the class after a health hazard evaluation, under 21 CFR 7.41. The firm doesn't pick it. The definitions sit in 21 CFR 7.3(m):
- Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death.
- Class II: may cause temporary or medically reversible adverse health consequences, or the chance of serious consequences is remote.
- Class III: not likely to cause adverse health consequences.
Some Enforcement Report entries show not yet classified. FDA usually sets the class only after the firm provides all the information it needs, and a firm's notice can come out well before that.
The class reflects the hazard, not the type of defect. Particulate contamination led to Class I in two recalls reported September 2, 2026: Fresenius Kabi Tyenne (tocilizumab-aazg) vials for glass particles, and B. Braun Lactated Ringer's Injection for particulate matter. A subpotent KIMMTRAK injection reported September 10, 2025 was Class II. Fresenius Kabi epinephrine vials that failed impurities and degradation specifications were Class III.
Drug recalls vs market withdrawals and safety alerts
Under 21 CFR 7.3, a recall is a firm's removal or correction of a marketed product that FDA considers in violation of the laws it administers, and against which it would take legal action such as seizure. A correction can be relabeling, repair or destruction without physical removal.
A market withdrawal involves a minor violation not subject to FDA legal action, or no violation at all, such as normal stock rotation. FDA's own example is a product pulled for tampering with no sign of manufacturing or distribution problems. A stock recovery covers product that is not yet marketed, or not yet out of the firm's direct control, when no part of the lot has been released. Neither is a recall, and neither gets a class. 21 CFR 7.50 keeps both out of the Enforcement Report.
A Drug Safety Communication is FDA information for patients and health care professionals about a new safety issue with a medicine. It may come with changes to the prescribing information or Medication Guide. The communication itself is not a recall. A recall removes or corrects a product under the definition above.
How pharmaceutical recalls work
Most drug recalls are voluntary. Under 21 CFR 7.40 a firm can start one at any time, or FDA can request one in urgent cases. If the firm refuses, FDA can seize the product or go to court. FDA can order a recall for some products, including controlled substances under section 569D of the FD&C Act. The Tyenne recall record, for example, shows "Voluntary: Firm initiated" in the voluntary_mandated field.
Under 21 CFR Part 7, the firm's recall strategy (7.42) sets the depth (consumer, retail or wholesale) and whether a public warning goes out. Recall letters for Class I and II are marked "urgent" (7.49). Firms send status reports generally every 2 to 4 weeks (7.53). FDA terminates the recall in writing once all reasonable efforts are made (7.55). FDA's Initiation of Voluntary Recalls guidance (final, March 2022) covers the firm side in more detail.
If you take a recalled medicine
Check the lot number on your package against the recall notice. FDA's patient guidance says that for Class I recalls you should follow the recalling company's instructions. For Class II and III, consumers "can generally continue taking the medicine unless the recalling company provides other instructions." Don't just stop. FDA warns that stopping can sometimes be more harmful than continuing, so talk to your doctor or pharmacist first. FDA describes the usual recall depth as consumer level for Class I, retail for Class II and wholesale for Class III.
Report a problem with a medicine through MedWatch: Form 3500 for health professionals, Form 3500B for consumers, or by phone at 1-888-463-6332.
RegAffairs AI's drug recalls answer shows how to check FDA recall data by product or firm, with citations.