[ 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.
3,493 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-07-01 | Class I | Utz Quality Foods, LLCH-1114-2026 | Potential presence of Salmonella. | Environmental Monitoring |
| 2026-07-01 | Class I | Prime Food Processing LLC.H-1080-2026 | Improperly eviscerated which may result in Clostridium botulinum contamination | Environmental Monitoring |
| 2026-07-01 | Class II | Joy Gourmet Foods LLC.H-1085-2026 | Product not adequately pasteurized | — |
| 2026-07-01 | Class I | CareFusion 213, LLCD-0624-2026 | Non-Sterility: Due to presence of Aspergillus penicillioides. | Environmental Monitoring |
| 2026-07-01 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0628-2026 | Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets. | Documentation & Change Control |
| 2026-07-01 | Class II | The Harvard Drug Group LLCD-0609-2026 | Subpotent Drug | Validation & Qualification |
| 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 I | Medline Industries, LPZ-2455-2026 | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier. | — |
| 2026-07-01 | Class II | Amgen, Inc.D-0615-2026 | Presence of Foreign Substance. | — |
| 2026-07-01 | Class II | Ajanta Pharma USA IncD-0611-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class III | ANI Pharmaceuticals, Inc.D-0619-2026 | Presence of foreign substance | — |
| 2026-07-01 | Class II | Medtronic Perfusion SystemsZ-2575-2026 | During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. | Documentation & Change Control |
| 2026-07-01 | Class II | PReye LLCD-0621-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 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 | Elevate Oral CareD-0627-2026 | sub potency | Validation & Qualification |
| 2026-07-01 | Class II | TMJ Solutions IncZ-2524-2026 | Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite. | Documentation & Change Control |
| 2026-07-01 | Class II | Amgen, Inc.D-0614-2026 | CGMP Deviations | Risk Management & CAPA |
| 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 | Amgen, Inc.D-0612-2026 | Presence of Foreign Substance. | — |
| 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 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 | Amgen, Inc.D-0613-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class II | Amgen, Inc.D-0616-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class II | Medline Industries, LPZ-2593-2026 | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. | Documentation & Change Control |
| 2026-07-01 | Class II | Direct RxD-0617-2026 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | 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.