[ 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.

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839 matching recalls
DateClassFirmReasonQuality domain
2026-03-25Class IISOMERSET THERAPEUTICS LLCD-0398-2026Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.Validation & Qualification
2026-03-25Class IIIAnnora Pharma Private LimitedD-0391-2026Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg—
2026-03-25Class ICardinal Health 200, LLCD-0528-2026Non-Sterility: microbial contamination identified as Paenibacillus phoenicisEnvironmental Monitoring
2026-03-25Class IIApotex Corp.D-0407-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-03-18Class IIZydus Pharmaceuticals (USA) IncD-0400-2026Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.—
2026-03-11Class IIACME UNITED CORPORATIOND-0372-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0362-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIHTO Nevada Inc. dba KirkmanD-0387-2026Stability Data Does Not Support Expiry Date.Validation & Qualification
2026-03-11Class IIICipla USA, Inc.D-0382-2026Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.Validation & Qualification
2026-03-11Class IANTHONY TRINH, 123Herbals LLCD-0388-2026Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.Documentation & Change Control
2026-03-11Class IIHTO Nevada Inc. dba KirkmanD-0386-2026Stability Data Does Not Support Expiry Date.Validation & Qualification
2026-03-11Class IIACME UNITED CORPORATIOND-0364-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIHTO Nevada Inc. dba KirkmanD-0385-2026Stability Data Does Not Support Expiry Date.Validation & Qualification
2026-03-11Class IIACME UNITED CORPORATIOND-0375-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0366-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0376-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0363-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IITeva Pharmaceuticals USA, IncD-0356-2026Failed Dissolution SpecificationsValidation & Qualification
2026-03-11Class IIACME UNITED CORPORATIOND-0359-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIRadnostixD-0389-2026Presence of Particulate Matter: Due to production issuesEnvironmental Monitoring
2026-03-11Class IIACME UNITED CORPORATIOND-0374-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IINew Life Pharma LLCD-0393-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-03-11Class IIACME UNITED CORPORATIOND-0370-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IMohamed HagarD-0396-2026Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).Documentation & Change Control
2026-03-11Class IIHarbin Jixianglong Biotech Co., Ltd.D-0380-2026CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distributionEnvironmental 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.