[ 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
2026-07-01	Class II	Ajanta Pharma USA IncD-0611-2026	CGMP Deviations	Risk Management & CAPA
2026-07-01	Class I	CareFusion 213, LLCD-0624-2026	Non-Sterility: Due to presence of Aspergillus penicillioides.	Environmental Monitoring
2026-06-24	Class II	Keystone IndustriesD-0602-2026	Defective container:may contain bottles with incomplete seals	—
2026-06-24	Class II	Dabur India LimitedD-0642-2026	CGMP Deviations; deficiencies observed during FDA inspection	Risk Management & CAPA
2026-06-24	Class III	Sandoz IncD-0608-2026	Labeling: Incorrect or Missing Lot and/or Exp Date	Documentation & Change Control
2026-06-24	Class II	Dabur India LimitedD-0631-2026	CGMP Deviations; deficiencies observed during FDA inspection	Risk Management & CAPA
2026-06-24	Class II	Dabur India LimitedD-0633-2026	CGMP Deviations; deficiencies observed during FDA inspection	Risk Management & CAPA
2026-06-24	Class II	Glenmark Pharmaceuticals Inc., USAD-0588-2026	Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.	Validation & Qualification
2026-06-24	Class II	Keystone IndustriesD-0605-2026	Defective container:may contain bottles with incomplete seals	—
2026-06-24	Class II	Dabur India LimitedD-0630-2026	CGMP Deviations; deficiencies observed during FDA inspection	Risk Management & CAPA
2026-06-24	Class II	Dabur India LimitedD-0636-2026	CGMP Deviations; deficiencies observed during FDA inspection	Risk Management & CAPA
2026-06-24	Class II	PAI Holdings LLCD-0592-2026	Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023	Validation & Qualification
2026-06-24	Class II	Dabur India LimitedD-0629-2026	CGMP Deviations; deficiencies observed during FDA inspection	Risk Management & CAPA
2026-06-24	Class II	Dabur India LimitedD-0637-2026	CGMP Deviations; deficiencies observed during FDA inspection	Risk Management & CAPA
2026-06-24	Class II	Ajanta Pharma USA IncD-0594-2026	Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.	Documentation & Change Control
2026-06-24	Class II	Dabur India LimitedD-0641-2026	CGMP Deviations; deficiencies observed during FDA inspection	Risk Management & CAPA
2026-06-24	Class II	Dabur India LimitedD-0639-2026	CGMP Deviations; deficiencies observed during FDA inspection	Risk Management & CAPA
2026-06-24	Class II	IntegraDose Compounding Services LLCD-0593-2026	Subpotent Drug	Validation & Qualification
2026-06-24	Class II	PAI Holdings LLCD-0589-2026	Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023	Validation & Qualification
2026-06-24	Class II	Dabur India LimitedD-0632-2026	CGMP Deviations; deficiencies observed during FDA inspection	Risk Management & CAPA
2026-06-24	Class II	PAI Holdings LLCD-0591-2026	Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023	Validation & Qualification
2026-06-24	Class II	PAI Holdings LLCD-0590-2026	Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023	Validation & Qualification
2026-06-24	Class II	Dabur India LimitedD-0635-2026	CGMP Deviations; deficiencies observed during FDA inspection	Risk Management & CAPA
2026-06-24	Class II	Dabur India LimitedD-0638-2026	CGMP Deviations; deficiencies observed during FDA inspection	Risk Management & CAPA
2026-06-24	Class II	Dabur India LimitedD-0640-2026	CGMP Deviations; deficiencies observed during FDA inspection	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.