[ 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
2026-05-13	Class II	Central Admixture Pharmacy Services, Inc (CAPS) Los AngelesD-0524-2026	Incorrect Product Formulation: product did not contain insulin as listed in the label.	Documentation & Change Control
2026-05-13	Class II	Ajanta Pharma Ltd.D-0516-2026	CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.	Validation & Qualification
2026-05-13	Class II	Ajanta Pharma Ltd.D-0514-2026	CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.	Validation & Qualification
2026-05-13	Class II	CareFusion 213, LLCD-0518-2026	Lack of assurance of Sterility: potential product contamination	Environmental Monitoring
2026-05-13	Class II	JB Chemicals and Pharmaceuticals LtdD-0520-2026	Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test	Validation & Qualification
2026-05-13	Class III	Unichem Pharmaceuticals USA Inc.D-0511-2026	Subpotent drug	Validation & Qualification
2026-05-13	Class II	Breckenridge Pharmaceutical, Inc.D-0522-2026	CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit	Validation & Qualification
2026-05-13	Class I	B BRAUN MEDICAL INCD-0540-2026	Presence of Particulate Matter.	Environmental Monitoring
2026-05-13	Class II	CareFusion 213, LLCD-0517-2026	Lack of assurance of Sterility: potential product contamination	Environmental Monitoring
2026-05-06	Class II	Thea Pharma, Inc.D-0501-2026	Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.	Environmental Monitoring
2026-05-06	Class II	Wells Pharma of Houston LLCD-0507-2026	cGMP deviations.	Risk Management & CAPA
2026-05-06	Class II	Hikma Pharmaceuticals USA INCD-0526-2026	This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.	Validation & Qualification
2026-05-06	Class II	Thea Pharma, Inc.D-0500-2026	Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.	Environmental Monitoring
2026-05-06	Class II	Alcon Research LLCD-0491-2026	Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.	Environmental Monitoring
2026-05-06	Class II	Wells Pharma of Houston LLCD-0502-2026	cGMP deviations.	Risk Management & CAPA
2026-05-06	Class II	Wells Pharma of Houston LLCD-0508-2026	cGMP deviations.	Risk Management & CAPA
2026-05-06	Class III	Water-Jel Technologies, LLCD-0509-2026	Failed PH Specifications	—
2026-05-06	Class II	SCOPE HEALTHD-0499-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-05-06	Class II	Alcon Research LLCD-0492-2026	Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.	Environmental Monitoring
2026-05-06	Class III	American Regent, Inc.D-0494-2026	Labeling: Missing Label	Documentation & Change Control
2026-05-06	Class II	Wells Pharma of Houston LLCD-0506-2026	cGMP deviations.	Risk Management & CAPA
2026-05-06	Class II	Wells Pharma of Houston LLCD-0504-2026	cGMP deviations.	Risk Management & CAPA
2026-05-06	Class II	Wells Pharma of Houston LLCD-0503-2026	cGMP deviations.	Risk Management & CAPA
2026-05-06	Class II	Wells Pharma of Houston LLCD-0505-2026	cGMP deviations.	Risk Management & CAPA
2026-04-29	Class II	Harrow Eye LLCD-0489-2026	Lack of Assurance of Sterility	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.