[ 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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3,493 matching recalls
DateClassFirmReasonQuality domain
2026-07-22Class IIBell Pharmaceuticals, IncD-0680-2026SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, IncD-0679-2026SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, IncD-0685-2026SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, IncD-0683-2026SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Validation & Qualification
2026-07-22Class IICareFusion 213, LLCD-0690-2026Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicatorEnvironmental Monitoring
2026-07-22Class IIBell Pharmaceuticals, IncD-0688-2026SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Validation & Qualification
2026-07-22Class IIPadagis US LLCD-0677-2026Subpotent Drug: Low out of specification assay results performed during long-term stability testing.Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, IncD-0687-2026SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, IncD-0678-2026SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, IncD-0681-2026SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, IncD-0682-2026SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, IncD-0684-2026SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, IncD-0686-2026SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Validation & Qualification
2026-07-22Class IFrutas y Hortalizas del Sur S.A.H-1181-2026Potential E. coli O145:H28 ContaminationEnvironmental Monitoring
2026-07-22Class IINutricia North AmericaH-1153-2026Subpotent 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
2026-07-22Class IIGE Medical Systems, LLCZ-2727-2026GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.—
2026-07-22Class IITosoh Bioscience IncZ-2746-2026The 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
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1166-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1172-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IINutricia North AmericaH-1152-2026Subpotent 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
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1160-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IIFayus Inc.H-1175-2026Undeclared peanutsDocumentation & Change Control
2026-07-22Class IIGELLERT GLOBAL GROUPH-1176-2026Foreign material (Glass) was found in the product.Environmental Monitoring
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1159-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IIChiesi USA, Inc.D-0689-2026Lack of Assurance of SterilityEnvironmental 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.