How many recalls has FDA Drug Safety issued?

FDA Drug Safety has issued 17,899 recalls tracked in our database. These include both active and historical recall actions. New recalls are added as they are published by the agency.

What types of products does FDA Drug Safety recall?

FDA Drug Safety is a federal agency responsible for product safety in its jurisdiction. Recalls cover products found to have safety defects, contamination, or regulatory violations. Each recall includes details about the affected product, hazard description, and remedy instructions.

What should I do if I own a recalled product?

Stop using the product immediately and follow the remedy instructions in the recall notice. This may include returning the product for a refund, receiving a free repair, or disposing of the product safely. Contact the manufacturer directly for specific remedy details.

2023 data Federal recall API Linked to agency record

FDA Drug Safety

All recall actions attributed to FDA Drug Safety in our federal database. Each record links back to the agency's official notice so you can verify status, remedy, and amendments before acting.

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U.S. Food and Drug Administration — Drug recalls and safety communications

17,899 recalls · Page 350 of 358

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FDA Drug Safety Recall Insight

According to PlainRecalls' agency ranking (distinct recall events, same sort as /agency), FDA Drug Safety sits #3 of 6 (3rd among 6 issuing agencies) with 17,899 notices, about 17.1% of the 104,423-record archive. The agency's stated scope - U.S. Food and Drug Administration — Drug recalls and safety communications - determines what classes of products flow through its recall pipeline and how quickly notices reach consumers. With 358 pages of records at 50 recalls per page, this archive represents one of the longest continuous federal enforcement histories accessible to the public.

Record window. FDA Drug Safety records in this archive begin in 2012 , later than the archive's earliest records (1995), so its all-time total spans fewer years than the longest-running agencies in the agency ranking. Counting only 2015 onward, the first year every agency covers, it has 14,526 recalls.

Looking at the 50 records on this page alone, the severity distribution skews toward 3 critical (Class I-equivalent) actions, 37 moderate recalls, and 10 lower-severity notices. Approximately 50 of 50 entries name a specific recalling firm, while 50 disclose a unit count, the gap reflects regulatory filing norms where firms disclose lot numbers or distribution channels instead of absolute quantities. This page spans recalls from Dec 5, 2012 to Jan 9, 2013, covering 21 distinct firms. Severity mix is a leading indicator: a page weighted toward critical classifications usually signals an active public-health concern, while lower-severity clusters often represent labeling, undeclared-allergen, or minor design corrections.

Agency-level browsing is useful when a defect pattern crosses categories, for example, a supplier contamination can trigger dozens of downstream recalls that share no obvious product tag but a single issuing agency. Use the pagination below to scan the full archive, or combine this agency filter with category and manufacturer views elsewhere on PlainRecalls to intersect the data. Recall records are sourced directly from FDA Drug Safety's public enforcement feeds and are updated as the agency publishes new notices; the federal record is the authoritative version, and this page aggregates what the agency itself has released. For high-stakes decisions, medical, automotive, or childcare, always click through to the recall detail page and cross-verify the recall number against the agency's current site. Record counts reflect all indexed actions regardless of status (ongoing, terminated, or completed).

Moderate Jan 9, 2013