[ FDA ENFORCEMENT INTELLIGENCE ]

Learn from the record. Every FDA recall is a quality signal.

Live drug, device & food recall data from the FDA (openFDA enforcement) — food spanning dietary supplements, cosmetics & animal food — mapped to the GxP quality domains SPEQ assesses, so you can see where control breaks down across every regulated industry.

1,000

Total recalls

217

Class I (most serious)

167

Drug

515

Device

318

Food / supplement / cosmetic

Last 12 months · latest report 2026-07-22 · source: openFDA enforcement

RECALLS BY CLASSIFICATION · MONTHLY

RECALL REASONS BY QUALITY DOMAIN

Domain mapping is a SPEQ interpretation of the FDA recall reason, not an official FDA classification.

315 matching recalls

Date	Class	Firm	Reason	Quality domain
2026-04-15	Class II	Cook IncorporatedZ-1792-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1778-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1782-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Viatris, Inc.D-0444-2026	Failed Dissolution Specifications	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1786-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1790-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Teva Pharmaceuticals USA, IncD-0445-2026	Superpotent and Subpotent	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1779-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1781-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1777-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1780-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Brahms GmbHZ-1795-2026	Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1785-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1789-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1788-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Teva Pharmaceuticals USA, IncD-0446-2026	Superpotent and Subpotent	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1784-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1783-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1791-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1775-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-15	Class II	Cook IncorporatedZ-1787-2026	Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.	Validation & Qualification
2026-04-08	Class II	Burlington Medical, LLCZ-1758-2026	Potential for attenuation degradation over time, decreasing the lifespan.	Validation & Qualification
2026-04-08	Class II	Burlington Medical, LLCZ-1764-2026	Potential for attenuation degradation over time, decreasing the lifespan.	Validation & Qualification
2026-04-08	Class II	Burlington Medical, LLCZ-1760-2026	Potential for attenuation degradation over time, decreasing the lifespan.	Validation & Qualification
2026-04-08	Class II	Burlington Medical, LLCZ-1756-2026	Potential for attenuation degradation over time, decreasing the lifespan.	Validation & Qualification

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Data: U.S. FDA openFDA enforcement API. Quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Recall details are as reported by the FDA.