[ 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
2026-07-15	Class II	Reliance Life Sciences Private LimitedD-0674-2026	Lack of Sterility Assurance	Environmental Monitoring
2026-07-15	Class II	Gasco Industrial Corp.D-0670-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	Gasco Industrial Corp.D-0668-2026	Subpotent drug	Validation & Qualification
2026-07-08	Class II	McKessonD-0714-2026	Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.	Documentation & Change Control
2026-07-08	Class II	CareFusion 213, LLCD-0650-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class II	Blaine Labs IncD-0695-2026	CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	Validation & Qualification
2026-07-08	Class II	Blaine Labs IncD-0693-2026	CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated	Environmental Monitoring
2026-07-08	Class II	CareFusion 213, LLCD-0646-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class II	CareFusion 213, LLCD-0644-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class II	Blaine Labs IncD-0696-2026	CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	Validation & Qualification
2026-07-08	Class II	Lupin Pharmaceuticals Inc.D-0655-2026	Presence of Foreign Substance	—
2026-07-08	Class II	CareFusion 213, LLCD-0651-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class III	SUN PHARMACEUTICAL INDUSTRIES INCD-0654-2026	Failed Impurities/Degradation Specifications	Validation & Qualification
2026-07-08	Class I	Blaine Labs IncD-0692-2026	Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp	Environmental Monitoring
2026-07-08	Class II	CareFusion 213, LLCD-0652-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class II	Lupin Pharmaceuticals Inc.D-0723-2026	CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.	Validation & Qualification
2026-07-08	Class II	Blaine Labs IncD-0694-2026	CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	Validation & Qualification
2026-07-08	Class II	Blaine Labs IncD-0698-2026	CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	Validation & Qualification
2026-07-08	Class II	Asclemed USA Inc.D-0658-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-07-08	Class II	Cipla USA, Inc.D-0661-2026	cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).	Risk Management & CAPA
2026-07-08	Class II	Blaine Labs IncD-0699-2026	CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated	Environmental Monitoring
2026-07-08	Class II	Blaine Labs IncD-0697-2026	CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	Validation & Qualification
2026-07-08	Class II	CareFusion 213, LLCD-0643-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class II	ACCORD HEALTHCARE, INC.D-0656-2026	Subpotent Drug	Validation & Qualification
2026-07-08	Class II	Cipla USA, Inc.D-0676-2026	cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).	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.