[ 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 |
|---|---|---|---|---|
| 2025-11-05 | Class II | Amerisource Health Services LLCD-0103-2026 | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit | Validation & Qualification |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0137-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0128-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-10-29 | Class II | Medline Industries, LPD-0035-2026 | Subpotent Drug | Validation & Qualification |
| 2025-10-29 | Class II | Aspiro Pharma LimitedD-0036-2026 | Presence of Particulate Matter: Particulate matter identified as glass | Environmental Monitoring |
| 2025-10-29 | Class II | ibspotD-0098-2026 | Marketed Without an Approved NDA/ANDA | — |
| 2025-10-29 | Class III | JB Chemicals and Pharmaceuticals LtdD-0033-2026 | Tablet/Capsules Imprinted with Wrong ID | Documentation & Change Control |
| 2025-10-29 | Class II | Bristol-Myers Squibb CompanyD-0097-2026 | Lack of Assurance of Sterility. | Environmental Monitoring |
| 2025-10-29 | Class II | Church & Dwight Co., Inc.D-0095-2026 | Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient. | Documentation & Change Control |
| 2025-10-29 | Class II | USV Private LimitedD-0034-2026 | Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. | Validation & Qualification |
| 2025-10-29 | Class II | Lannett Company Inc.D-0096-2026 | Failed Dissolution Specifications | Validation & Qualification |
| 2025-10-29 | Class II | The Harvard Drug Group LLCD-0030-2026 | Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . | Validation & Qualification |
| 2025-10-29 | Class III | JB Chemicals and Pharmaceuticals LtdD-0032-2026 | Tablet/Capsules Imprinted with Wrong ID | Documentation & Change Control |
| 2025-10-29 | Class II | The Harvard Drug Group LLCD-0031-2026 | Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . | Validation & Qualification |
| 2025-10-29 | Class II | Graviti Pharmaceuticals Private LimitedD-0037-2026 | Failed Tablet/Capsule Specifications | — |
| 2025-10-22 | Class II | ASTRAZENECA PHARMACEUTICALSD-0028-2026 | Lack of Assurance of Sterility: | Environmental Monitoring |
| 2025-10-22 | Class II | Rising Pharma Holding, Inc.D-0029-2026 | Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg). | Documentation & Change Control |
| 2025-10-22 | Class III | STAQ Pharma, Inc.D-0024-2026 | Labeling: Incorrect or Missing Lot and/or Exp Date | Documentation & Change Control |
| 2025-10-22 | Class II | SV Labs Prescott CorporationD-0022-2026 | cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing. | Environmental Monitoring |
| 2025-10-22 | Class III | STAQ Pharma, Inc.D-0025-2026 | Labeling: Incorrect or Missing Lot and/or Exp Date | Documentation & Change Control |
| 2025-10-22 | Class II | Ascend Laboratories, LLCD-0018-2026 | Failed Dissolution Specifications | Validation & Qualification |
| 2025-10-22 | Class II | Ascend Laboratories, LLCD-0017-2026 | Failed Dissolution Specifications | Validation & Qualification |
| 2025-10-22 | Class I | IntegraDose Compounding Services LLCD-0015-2026 | Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. | Validation & Qualification |
| 2025-10-22 | Class II | Ascend Laboratories, LLCD-0019-2026 | Failed Dissolution Specifications | Validation & Qualification |
| 2025-10-22 | Class II | Ascend Laboratories, LLCD-0020-2026 | Failed Dissolution Specifications | 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.