[ 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
2026-04-22	Class II	SUN PHARMACEUTICAL INDUSTRIES INCD-0476-2026	Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.	Validation & Qualification
2026-04-22	Class II	Owen Biosciences Inc.D-0453-2026	Chemical contamination: Presence of benzene	Environmental Monitoring
2026-04-22	Class II	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0458-2026	This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.	Risk Management & CAPA
2026-04-22	Class II	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0466-2026	This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.	Risk Management & CAPA
2026-04-22	Class II	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0462-2026	This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.	Risk Management & CAPA
2026-04-22	Class II	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0470-2026	This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.	Risk Management & CAPA
2026-04-22	Class II	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0460-2026	This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.	Risk Management & CAPA
2026-04-22	Class II	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0461-2026	This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.	Risk Management & CAPA
2026-04-22	Class II	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0469-2026	This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.	Risk Management & CAPA
2026-04-22	Class III	Island Kinetics, Inc. d.b.a. CoValence LaboratoriesD-0482-2026	Subpotent Drug	Validation & Qualification
2026-04-22	Class II	Huons Co., Ltd.D-0531-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-22	Class II	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0465-2026	This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.	Risk Management & CAPA
2026-04-22	Class III	Avantor Performance Materials LLCD-0488-2026	Subpotent drug	Validation & Qualification
2026-04-22	Class II	International Medication Systems Ltd.D-0483-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-22	Class II	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0456-2026	This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.	Risk Management & CAPA
2026-04-22	Class II	Island Kinetics, Inc. d.b.a. CoValence LaboratoriesD-0487-2026	Failed Stability Specifications	Validation & Qualification
2026-04-22	Class III	Island Kinetics, Inc. d.b.a. CoValence LaboratoriesD-0480-2026	Subpotent Drug	Validation & Qualification
2026-04-22	Class II	PAYLESS COMPOUNDERS, LLCD-0471-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-22	Class II	Owen Biosciences Inc.D-0454-2026	Chemical contamination: Presence of benzene	Environmental Monitoring
2026-04-22	Class II	Owen Biosciences Inc.D-0452-2026	Chemical contamination: Presence of benzene	Environmental Monitoring
2026-04-22	Class II	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0463-2026	This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.	Risk Management & CAPA
2026-04-22	Class III	Island Kinetics, Inc. d.b.a. CoValence LaboratoriesD-0481-2026	Subpotent Drug	Validation & Qualification
2026-04-22	Class II	Owen Biosciences Inc.D-0455-2026	Chemical contamination: Presence of benzene	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0433-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-15	Class II	Fresenius Kabi USA, LLCD-0436-2026	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.