[ 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.

839 matching recalls

Date	Class	Firm	Reason	Quality domain
2026-01-21	Class III	SUN PHARMACEUTICAL INDUSTRIES INCD-0256-2026	Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.	Validation & Qualification
2026-01-21	Class II	Alvogen, IncD-0259-2026	Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.	Documentation & Change Control
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0284-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0276-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class III	SUN PHARMACEUTICAL INDUSTRIES INCD-0257-2026	Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.	Validation & Qualification
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0263-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0281-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0273-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0269-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	Encon Safety Products CoD-0260-2026	cGMP deviations.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0271-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0268-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0261-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0287-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0277-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0270-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0279-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0278-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-14	Class III	Alembic Pharmaceuticals LimitedD-0248-2026	Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.	Validation & Qualification
2026-01-14	Class II	SpecGx, LLCD-0255-2026	Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.	—
2026-01-14	Class II	SpecGx, LLCD-0254-2026	Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.	—
2026-01-14	Class II	AvKARED-0292-2026	Out of specification for dissolution.	Validation & Qualification
2026-01-14	Class II	Signature Formulations, LLCD-0253-2026	cGMP Deviations	Risk Management & CAPA
2026-01-14	Class II	Imprimis NJOF, LLCD-0251-2026	Presence of particulate matter - Glass like particles.	Environmental Monitoring
2026-01-14	Class II	Signature Formulations, LLCD-0252-2026	cGMP Deviations	Risk Management & CAPA

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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.