[ 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
214
Class I (most serious)
167
Drug
520
Device
313
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.
3,465 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-05-13 | Class II | Green Organic VegetablesH-0694-2026 | Foreign object: metal pieces | Environmental Monitoring |
| 2026-05-13 | Class II | Walker Honey CoH-0705-2026 | Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic. | — |
| 2026-05-06 | Class II | Thea Pharma, Inc.D-0501-2026 | Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. | Environmental Monitoring |
| 2026-05-06 | Class II | Wells Pharma of Houston LLCD-0507-2026 | cGMP deviations. | Risk Management & CAPA |
| 2026-05-06 | Class II | Thea Pharma, Inc.D-0500-2026 | Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. | Environmental Monitoring |
| 2026-05-06 | Class II | Wells Pharma of Houston LLCD-0506-2026 | cGMP deviations. | Risk Management & CAPA |
| 2026-05-06 | Class II | Wells Pharma of Houston LLCD-0504-2026 | cGMP deviations. | Risk Management & CAPA |
| 2026-05-06 | Class II | Wells Pharma of Houston LLCD-0503-2026 | cGMP deviations. | Risk Management & CAPA |
| 2026-05-06 | Class II | Wells Pharma of Houston LLCD-0505-2026 | cGMP deviations. | Risk Management & CAPA |
| 2026-05-06 | Class III | Water-Jel Technologies, LLCD-0509-2026 | Failed PH Specifications | — |
| 2026-05-06 | Class II | Wells Pharma of Houston LLCD-0502-2026 | cGMP deviations. | Risk Management & CAPA |
| 2026-05-06 | Class II | Hikma Pharmaceuticals USA INCD-0526-2026 | This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side. | Validation & Qualification |
| 2026-05-06 | Class II | SCOPE HEALTHD-0499-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-05-06 | Class II | Alcon Research LLCD-0492-2026 | Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. | Environmental Monitoring |
| 2026-05-06 | Class II | Alcon Research LLCD-0491-2026 | Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality. | Environmental Monitoring |
| 2026-05-06 | Class III | American Regent, Inc.D-0494-2026 | Labeling: Missing Label | Documentation & Change Control |
| 2026-05-06 | Class II | Philips North AmericaZ-1954-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class II | Guangdong Zonegoing Food Co., LTDH-0677-2026 | Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40). | Documentation & Change Control |
| 2026-05-06 | Class II | Philips North AmericaZ-1961-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class II | Medline Industries, LPZ-2021-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class II | Wells Pharma of Houston LLCD-0508-2026 | cGMP deviations. | Risk Management & CAPA |
| 2026-05-06 | Class II | Philips North AmericaZ-1957-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class II | Immuno-Mycologics, IncZ-1984-2026 | Neutralization Buffer may contain contaminants | — |
| 2026-05-06 | Class II | Merit Medical Systems, Inc.Z-2004-2026 | catheter may experience resistance when being advanced over the guidewire | — |
| 2026-05-06 | Class II | Hadson (Toko) Trading Co. Inc.H-0679-2026 | Contains undeclared FD&C Yellow 6 | Documentation & Change Control |
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.