[ 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.

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315 matching recalls
DateClassFirmReasonQuality domain
2026-04-08Class IIAppco Pharma LLCD-0420-2026cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.Validation & Qualification
2026-04-08Class IIALEMBIC PHARMACEUTICALS, INC.drug-20260408-ALEMBIC PHARMACEUTICALS, INC.Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1762-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1754-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1763-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-08Class IISiemens Healthcare Diagnostics, Inc.Z-1657-2026A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1765-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1753-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1759-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1760-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1756-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1758-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1764-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1755-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1757-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-08Class IIBurlington Medical, LLCZ-1761-2026Potential for attenuation degradation over time, decreasing the lifespan.Validation & Qualification
2026-04-01Class IIOrthalign, IncZ-1629-2026Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)Validation & Qualification
2026-04-01Class IIOrthalign, IncZ-1630-2026Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)Validation & Qualification
2026-04-01Class IIMACLEODS PHARMA USA, INCD-0403-2026Subpotent DrugValidation & Qualification
2026-03-25Class IIIWinder Laboratories, LLCH-0569-2026Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.Validation & Qualification
2026-03-25Class IISOMERSET THERAPEUTICS LLCD-0398-2026Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.Validation & Qualification
2026-03-11Class IITeva Pharmaceuticals USA, IncD-0356-2026Failed Dissolution SpecificationsValidation & Qualification
2026-03-11Class IIRising Pharma Holding, Inc.D-0384-2026Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testingValidation & Qualification
2026-03-11Class IIICipla USA, Inc.D-0381-2026Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.Validation & Qualification
2026-03-11Class IIHTO Nevada Inc. dba KirkmanD-0385-2026Stability Data Does Not Support Expiry Date.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.