[ 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
2026-03-11	Class II	ACME UNITED CORPORATIOND-0363-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class II	New Life Pharma LLCD-0392-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-03-11	Class II	New Life Pharma LLCD-0394-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-03-11	Class II	ACME UNITED CORPORATIOND-0370-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class I	Mohamed HagarD-0396-2026	Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).	Documentation & Change Control
2026-03-11	Class II	Teva Pharmaceuticals USA, IncD-0354-2026	Failed Dissolution Specifications	Validation & Qualification
2026-03-11	Class II	Teva Pharmaceuticals USA, IncD-0355-2026	Failed Dissolution Specifications	Validation & Qualification
2026-03-11	Class II	ACME UNITED CORPORATIOND-0378-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class II	The Harvard Drug Group LLCD-0383-2026	Defective container; inadequately sealed blister packaging.	Documentation & Change Control
2026-03-11	Class II	ACME UNITED CORPORATIOND-0373-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class II	ACME UNITED CORPORATIOND-0369-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class II	ACME UNITED CORPORATIOND-0358-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class II	ACME UNITED CORPORATIOND-0362-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class II	Harbin Jixianglong Biotech Co., Ltd.D-0379-2026	CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution	Environmental Monitoring
2026-03-11	Class II	ACME UNITED CORPORATIOND-0361-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class II	ACME UNITED CORPORATIOND-0372-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class I	ANTHONY TRINH, 123Herbals LLCD-0388-2026	Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.	Documentation & Change Control
2026-03-11	Class III	Cipla USA, Inc.D-0381-2026	Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.	Validation & Qualification
2026-03-11	Class II	ACME UNITED CORPORATIOND-0367-2026	CGMP Deviations	Risk Management & CAPA
2026-03-11	Class III	Cipla USA, Inc.D-0382-2026	Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.	Validation & Qualification
2026-03-11	Class II	New Life Pharma LLCD-0395-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-03-11	Class I	StuffbyNainaxD-0397-2026	Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil	Documentation & Change Control
2026-03-11	Class II	ACME UNITED CORPORATIOND-0371-2026	CGMP Deviations	Risk Management & CAPA
2026-03-04	Class II	Wizcure Pharmaa Private LimitedD-0351-2026	Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.	Environmental Monitoring
2026-03-04	Class II	AvKARED-0341-2026	Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.	Validation & Qualification

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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.