[ 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 |
|---|---|---|---|---|
| 2025-11-26 | Class I | Otsuka ICU Medical LLCD-0180-2026 | Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq | Documentation & Change Control |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0171-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0174-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | Park Avenue CompoundingD-0178-2026 | CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. | Risk Management & CAPA |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0172-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class III | Imprimis NJOF, LLCD-0157-2026 | Subpotent Drug | Validation & Qualification |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0170-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0168-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0173-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0162-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0165-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0164-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0163-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0176-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class I | Otsuka ICU Medical LLCD-0181-2026 | Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq | Documentation & Change Control |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0177-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0166-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0167-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0169-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | Zydus Pharmaceuticals (USA) IncD-0159-2026 | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules. | Validation & Qualification |
| 2025-11-26 | Class III | Alembic Pharmaceuticals LimitedD-0156-2026 | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Validation & Qualification |
| 2025-11-12 | Class II | Aero HealthcareD-0155-2026 | Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg. | Documentation & Change Control |
| 2025-11-12 | Class II | Zydus Pharmaceuticals (USA) IncD-0152-2026 | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Validation & Qualification |
| 2025-11-12 | Class II | Zydus Pharmaceuticals (USA) IncD-0154-2026 | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Validation & Qualification |
| 2025-11-12 | Class II | Teva Pharmaceuticals USA, IncD-0151-2026 | Subpotent drug; Clavulanate Potassium component | Validation & Qualification |
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.