[ 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
2026-07-22	Class II	Nutricia North AmericaH-1153-2026	Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.	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-0683-2026	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	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	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	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	Tosoh Bioscience IncZ-2746-2026	The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.	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
2026-07-22	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	Nutricia North AmericaH-1152-2026	Subpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.	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-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-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-0686-2026	SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).	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	ONESOURCE SPECIALTY PHARMA LIMITEDD-0662-2026	Failed Impurities/Degradation Specifications	Validation & Qualification
2026-07-15	Class II	Gasco Industrial Corp.D-0668-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	Gasco Industrial Corp.D-0669-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	Gasco Industrial Corp.D-0665-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	Gasco Industrial Corp.D-0670-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	QuVa Pharma, Inc.D-0664-2026	Failed Impurities/Degradation Specifications	Validation & Qualification
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	Siemens Healthcare Diagnostics, Inc.Z-2703-2026	The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.	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.