[ 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 |
|---|---|---|---|---|
| 2026-07-08 | Class II | ACCORD HEALTHCARE, INC.D-0656-2026 | Subpotent Drug | Validation & Qualification |
| 2026-07-08 | Class II | ACCORD BIOPHARMA INCD-0653-2026 | Lack of assurance of Sterility: | Environmental Monitoring |
| 2026-07-08 | Class II | Asclemed USA Inc.D-0659-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-07-08 | Class II | CareFusion 213, LLCD-0648-2026 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | Environmental Monitoring |
| 2026-07-08 | Class II | CareFusion 213, LLCD-0644-2026 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | Environmental Monitoring |
| 2026-07-08 | Class II | Blaine Labs IncD-0697-2026 | CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry | Validation & Qualification |
| 2026-07-08 | Class II | Cipla USA, Inc.D-0676-2026 | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Risk Management & CAPA |
| 2026-07-08 | Class II | CareFusion 213, LLCD-0645-2026 | Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel | Environmental Monitoring |
| 2026-07-08 | Class II | Asclemed USA Inc.D-0658-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-07-01 | Class III | ANI Pharmaceuticals, Inc.D-0619-2026 | Presence of foreign substance | — |
| 2026-07-01 | Class I | CareFusion 213, LLCD-0625-2026 | Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. | Environmental Monitoring |
| 2026-07-01 | Class II | Ajanta Pharma USA IncD-0611-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class II | Amgen, Inc.D-0613-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class II | Annora Pharma Private LimitedD-0626-2026 | Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg. | Documentation & Change Control |
| 2026-07-01 | Class II | Amgen, Inc.D-0616-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class II | Amgen, Inc.D-0614-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class II | Amgen, Inc.D-0615-2026 | Presence of Foreign Substance. | — |
| 2026-07-01 | Class II | Direct RxD-0617-2026 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Validation & Qualification |
| 2026-07-01 | Class II | Central Admixture Pharmacy Services, Inc.D-0618-2026 | Incorrect product formulation: bag did not contain copper and famotidine per label. | Documentation & Change Control |
| 2026-07-01 | Class II | PReye LLCD-0621-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-07-01 | Class II | CareFusion 213, LLCD-0623-2026 | Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. | Environmental Monitoring |
| 2026-07-01 | Class II | Amgen, Inc.D-0612-2026 | Presence of Foreign Substance. | — |
| 2026-07-01 | Class II | Elevate Oral CareD-0627-2026 | sub potency | Validation & Qualification |
| 2026-07-01 | Class II | CareFusion 213, LLCD-0622-2026 | Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. | Environmental Monitoring |
| 2026-07-01 | Class II | The Harvard Drug Group LLCD-0609-2026 | Subpotent Drug | 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.