[ 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
2026-07-22	Class II	Bell Pharmaceuticals, IncD-0684-2026	SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Validation & Qualification
2026-07-22	Class II	Bell Pharmaceuticals, IncD-0683-2026	SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Validation & Qualification
2026-07-22	Class II	Chiesi USA, Inc.D-0689-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-07-22	Class II	Bell Pharmaceuticals, IncD-0686-2026	SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Validation & Qualification
2026-07-22	Class II	Bell Pharmaceuticals, IncD-0681-2026	SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Validation & Qualification
2026-07-22	Class II	Bell Pharmaceuticals, IncD-0679-2026	SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Validation & Qualification
2026-07-22	Class II	Padagis US LLCD-0677-2026	Subpotent Drug: Low out of specification assay results performed during long-term stability testing.	Validation & Qualification
2026-07-22	Class II	CareFusion 213, LLCD-0690-2026	Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator	Environmental Monitoring
2026-07-22	Class II	Bell Pharmaceuticals, IncD-0685-2026	SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Validation & Qualification
2026-07-22	Class II	Bell Pharmaceuticals, IncD-0688-2026	SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Validation & Qualification
2026-07-22	Class II	Bell Pharmaceuticals, IncD-0682-2026	SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Validation & Qualification
2026-07-22	Class II	Bell Pharmaceuticals, IncD-0680-2026	SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Validation & Qualification
2026-07-22	Class II	Bell Pharmaceuticals, IncD-0687-2026	SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Validation & Qualification
2026-07-22	Class II	Bell Pharmaceuticals, IncD-0678-2026	SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	Validation & Qualification
2026-07-15	Class II	Gasco Industrial Corp.D-0665-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	ONESOURCE SPECIALTY PHARMA LIMITEDD-0662-2026	Failed Impurities/Degradation Specifications	Validation & Qualification
2026-07-15	Class II	Shimoga ChemicalsD-0691-2026	cGMP deviations	Risk Management & CAPA
2026-07-15	Class II	Reliance Life Sciences Private LimitedD-0673-2026	Lack of Sterility Assurance	Environmental Monitoring
2026-07-15	Class II	Gasco Industrial Corp.D-0667-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	Gasco Industrial Corp.D-0666-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	BioMed Laboratories, LLC.D-0663-2026	Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.	Validation & Qualification
2026-07-15	Class II	Reliance Life Sciences Private LimitedD-0672-2026	Lack of Sterility Assurance	Environmental Monitoring
2026-07-15	Class II	Gasco Industrial Corp.D-0668-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	Gasco Industrial Corp.D-0670-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	Reliance Life Sciences Private LimitedD-0671-2026	Lack of Sterility Assurance	Environmental Monitoring

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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.