[ 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.
3,465 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0564-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0578-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2284-2026 | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. | — |
| 2026-06-10 | Class II | Asclemed USA Inc.D-0555-2026 | CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. | Validation & Qualification |
| 2026-06-10 | Class II | Ascend Laboratories, LLCD-0556-2026 | Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications | Validation & Qualification |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0562-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0598-2026 | Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona | Documentation & Change Control |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0561-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0576-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0574-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Kico Knee Innovation CompanyZ-2293-2026 | The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0566-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0567-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0559-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Advanced Bionics, LLCZ-2283-2026 | Due to incorrect shelf-life expiration date. | Validation & Qualification |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0575-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0571-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0572-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2287-2026 | During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0560-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0565-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Spectra Medical Devices, LlcD-0554-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0558-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0557-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0577-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
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.