[ 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
2026-04-29	Class II	Harrow Eye LLCD-0489-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-29	Class II	Leading Pharma, LLCD-0486-2026	CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.	Risk Management & CAPA
2026-04-29	Class III	Premier Dental Products CoD-0490-2026	Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.	Validation & Qualification
2026-04-29	Class II	B BRAUN MEDICAL INCD-0496-2026	Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.	Environmental Monitoring
2026-04-29	Class II	Teva Pharmaceuticals USA, IncD-0521-2026	Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin	Validation & Qualification
2026-04-29	Class II	The Harvard Drug Group LLCD-0493-2026	Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.	Validation & Qualification
2026-04-29	Class II	B BRAUN MEDICAL INCD-0498-2026	Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.	Environmental Monitoring
2026-04-29	Class II	Hetero Labs Limited (Unit V)D-0484-2026	Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."	—
2026-04-29	Class II	B BRAUN MEDICAL INCD-0495-2026	Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.	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 II	Huons Co., Ltd.D-0530-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-04-22	Class II	SUN PHARMACEUTICAL INDUSTRIES INCD-0477-2026	Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.	Validation & Qualification
2026-04-22	Class II	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-0457-2026	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-0464-2026	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-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-0467-2026	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	Owen Biosciences Inc.D-0454-2026	Chemical contamination: Presence of benzene	Environmental Monitoring
2026-04-22	Class II	Owen Biosciences Inc.D-0455-2026	Chemical contamination: Presence of benzene	Environmental Monitoring
2026-04-22	Class III	Island Kinetics, Inc. d.b.a. CoValence LaboratoriesD-0482-2026	Subpotent Drug	Validation & Qualification
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	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-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 II	Cipla USA, Inc.D-0451-2026	CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit	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.