[ 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.
409 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-04-29 | Class II | Angiodynamics, Inc.Z-1874-2026 | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0456-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0467-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0465-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Cipla USA, Inc.D-0451-2026 | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0464-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Cipla USA, Inc.D-0450-2026 | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0468-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0459-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0469-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0470-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Cipla USA, Inc.D-0449-2026 | CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0461-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0457-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0460-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0458-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0466-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Wilson-Cook Medical Inc.Z-1812-2026 | Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0462-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-22 | Class II | Xiamen Kang Zhongyuan Biotechnology Co., Ltd.D-0463-2026 | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. | Risk Management & CAPA |
| 2026-04-15 | Class II | Beckman Coulter, Inc.Z-1772-2026 | Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics | Risk Management & CAPA |
| 2026-04-08 | Class II | Medline Industries, LPZ-1691-2026 | Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process. | Risk Management & CAPA |
| 2026-04-08 | Class II | Medline Industries, LPZ-1690-2026 | Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process. | Risk Management & CAPA |
| 2026-04-08 | Class II | Imu-Tek Animal Health, IncorporatedH-0661-2026 | Product is potentially under-processed. | Risk Management & CAPA |
| 2026-04-08 | Class II | Imu-Tek Animal Health, IncorporatedH-0660-2026 | Product is potentially under-processed. | Risk Management & CAPA |
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.