[ 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 |
|---|---|---|---|---|
| 2026-04-15 | Class II | Fresenius Kabi USA, LLCD-0433-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-15 | Class II | Fresenius Kabi USA, LLCD-0425-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-15 | Class II | Fresenius Kabi USA, LLCD-0432-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-08 | Class II | Appco Pharma LLCD-0421-2026 | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. | Validation & Qualification |
| 2026-04-08 | Class II | K.C. Pharmaceuticals, IncD-0409-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-08 | Class II | K.C. Pharmaceuticals, IncD-0414-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-08 | Class II | K.C. Pharmaceuticals, IncD-0410-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-08 | Class II | K.C. Pharmaceuticals, IncD-0413-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-08 | Class II | Appco Pharma LLCD-0420-2026 | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. | Validation & Qualification |
| 2026-04-08 | Class II | K.C. Pharmaceuticals, IncD-0415-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-08 | Class II | K.C. Pharmaceuticals, IncD-0412-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-08 | Class II | K.C. Pharmaceuticals, IncD-0411-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-08 | Class II | Amneal Pharmaceuticals, LLCD-0408-2026 | Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH). | Validation & Qualification |
| 2026-04-08 | Class I | Amneal Pharmaceuticals, LLCD-0478-2026 | Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead. | Documentation & Change Control |
| 2026-04-08 | Class II | ALEMBIC PHARMACEUTICALS, INC.drug-20260408-ALEMBIC PHARMACEUTICALS, INC. | Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing. | Validation & Qualification |
| 2026-04-08 | Class II | Appco Pharma LLCD-0419-2026 | cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits. | Validation & Qualification |
| 2026-04-08 | Class II | K.C. Pharmaceuticals, IncD-0416-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-01 | Class II | MACLEODS PHARMA USA, INCD-0403-2026 | Subpotent Drug | Validation & Qualification |
| 2026-04-01 | Class II | Teva Pharmaceuticals USA, IncD-0406-2026 | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. | Environmental Monitoring |
| 2026-04-01 | Class II | Amerisource Health Services LLCD-0418-2026 | Failed tablet specifications. | — |
| 2026-04-01 | Class III | RadnostixD-0401-2026 | Failed Tablet/Capsule Specifications | — |
| 2026-04-01 | Class II | Chiesi USA, Inc.D-0402-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-01 | Class II | Teva Pharmaceuticals USA, IncD-0404-2026 | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. | Environmental Monitoring |
| 2026-04-01 | Class II | Teva Pharmaceuticals USA, IncD-0405-2026 | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. | Environmental Monitoring |
| 2026-03-25 | Class I | Cardinal Health 200, LLCD-0528-2026 | Non-Sterility: microbial contamination identified as Paenibacillus phoenicis | Environmental Monitoring |
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.