[ 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
2026-03-04	Class II	Wizcure Pharmaa Private LimitedD-0349-2026	Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.	Environmental Monitoring
2026-03-04	Class II	Wizcure Pharmaa Private LimitedD-0346-2026	Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.	Environmental Monitoring
2026-03-04	Class II	Wizcure Pharmaa Private LimitedD-0347-2026	Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.	Environmental Monitoring
2026-03-04	Class III	Slate Run PharmaceuticalsD-0343-2026	Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.	Documentation & Change Control
2026-03-04	Class II	LEO PHARMA INCD-0339-2026	Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.	Environmental Monitoring
2026-03-04	Class II	AgeboxD-0344-2026	Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren	Documentation & Change Control
2026-03-04	Class II	Wizcure Pharmaa Private LimitedD-0348-2026	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
2026-03-04	Class II	Wizcure Pharmaa Private LimitedD-0352-2026	Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.	Environmental Monitoring
2026-03-04	Class II	Wizcure Pharmaa Private LimitedD-0350-2026	Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.	Environmental Monitoring
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0314-2026	Presence of Foreign substance - potential presence of metal particulate matter	Environmental Monitoring
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0319-2026	Presence of Foreign substance - potential presence of metal particulate matter	Environmental Monitoring
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0317-2026	Presence of Foreign substance - potential presence of metal particulate matter	Environmental Monitoring
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0331-2026	Presence of Foreign substance - potential presence of metal particulate matter	Environmental Monitoring
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0329-2026	Presence of Foreign substance - potential presence of metal particulate matter	Environmental Monitoring
2026-02-18	Class II	Meitheal Pharmaceuticals, IncD-0340-2026	Defective Delivery System: Missing or duplicated needles within the injection kit	—
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0320-2026	Presence of Foreign substance - potential presence of metal particulate matter	Environmental Monitoring
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0322-2026	Presence of Foreign substance - potential presence of metal particulate matter	Environmental Monitoring
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0310-2026	Presence of Foreign substance - potential presence of metal particulate matter	Environmental Monitoring
2026-02-18	Class II	Fresenius Kabi Compounding, LLCD-0336-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-02-18	Class II	Fresenius Kabi Compounding, LLCD-0333-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0318-2026	Presence of Foreign substance - potential presence of metal particulate matter	Environmental Monitoring
2026-02-18	Class II	Pro Numb Tattoo Numbing Spray LLCD-0302-2026	cGMP deviations	Risk Management & CAPA
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0309-2026	Presence of Foreign substance - potential presence of metal particulate matter	Environmental Monitoring
2026-02-18	Class II	F.H. INVESTMENTS, Inc. (dba Asteria Health)D-0328-2026	Presence of Foreign substance - potential presence of metal particulate matter	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.