[ 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
2026-02-11	Class I	HANDELNINE GLOBAL LLCD-0332-2026	CGMP Deviations: product found to contain lead.	Risk Management & CAPA
2026-02-04	Class II	Greenstone LlcD-0299-2026	Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.	Documentation & Change Control
2026-02-04	Class II	Baxter Healthcare CorporationD-0296-2026	Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution	Environmental Monitoring
2026-02-04	Class III	Haleon US Holdings LLCD-0297-2026	Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.	Validation & Qualification
2026-02-04	Class II	Sato Pharmaceutical Co., LtdD-0298-2026	Failed Disintegration Specifications: above the time expected.	—
2026-02-04	Class III	NOVADOZ PHARMACEUTICALS LLCD-0300-2026	Failed Impurities/Degradation Specifications	Validation & Qualification
2026-01-28	Class II	Specialty Process Labs LLCD-0294-2026	Subpotent Drug	Validation & Qualification
2026-01-28	Class III	Cipla USA, Inc.D-0291-2026	Failed PH Specifications	—
2026-01-28	Class II	Zydus Pharmaceuticals (USA) IncD-0295-2026	Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules	Validation & Qualification
2026-01-28	Class II	Graviti Pharmaceuticals Private LimitedD-0293-2026	Presence of Foreign Substance	—
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0283-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0266-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0282-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	Cipla USA, Inc.D-0290-2026	Presence of Particulate Matter.	Environmental Monitoring
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0274-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0265-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0272-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0275-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0267-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0262-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0280-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0286-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	Advanced Pharmaceutical Technology, Inc.D-0258-2026	Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.	Environmental Monitoring
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0264-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA
2026-01-21	Class II	GOLD STAR DISTRIBUTION INCD-0285-2026	CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.	Risk Management & CAPA

Page 17 of 34

← Prev Next →

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.