FDA Drug Safety

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, 35 moderate recalls, and 12 lower-severity notices. Approximately 50 of 50 entries name a specific recalling firm, while 49 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 Nov 21, 2018 to Dec 19, 2018, covering 26 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).