[ 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.

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3,465 matching recalls
DateClassFirmReasonQuality domain
2026-05-27Class IJOHN B SANFILIPPO & SONS INCH-0833-2026potential presence of SalmonellaEnvironmental Monitoring
2026-05-27Class IILIQUID BLENZ CORPH-0786-2026May be under-processed resulting in growth of Clostridium botulinum and lists health claims.Environmental Monitoring
2026-05-27Class IPS Seasoning & Spices, Inc.H-0816-2026Product was made with milk powder recalled by the supplier due to Salmonella contamination.Environmental Monitoring
2026-05-27Class IIMedtronic Perfusion SystemsZ-2219-2026Certain lots of product have the potential for a sterile barrier breach.Environmental Monitoring
2026-05-27Class ISolina U.S. HoldingH-0820-2026potential to be contaminated with SalmonellaEnvironmental Monitoring
2026-05-27Class IPS Seasoning & Spices, Inc.H-0815-2026Product was made with milk powder recalled by the supplier due to Salmonella contamination.Environmental Monitoring
2026-05-27Class IGhirardelli Chocolate CompanyH-0839-2026Potential contamination with Salmonella.Environmental Monitoring
2026-05-27Class IGhirardelli Chocolate CompanyH-0847-2026Potential contamination with Salmonella.Environmental Monitoring
2026-05-27Class IIWellnov Supplements LLCH-0805-2026Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.Environmental Monitoring
2026-05-27Class IFontana Flavors, IncH-0813-2026Product was made with milk powder recalled by the supplier due to Salmonella contamination.Environmental Monitoring
2026-05-27Class IFontana Flavors, IncH-0811-2026Product was made with milk powder recalled by the supplier due to Salmonella contamination.Environmental Monitoring
2026-05-27Class IITANGENT ENDOSCOPY, LLCZ-2209-2026Affected devices exhibited fractures at the distal shaft tip without complete detachment.—
2026-05-27Class IPS Seasoning & Spices, Inc.H-0818-2026Product was made with milk powder recalled by the supplier due to Salmonella contamination.Environmental Monitoring
2026-05-27Class IILIQUID BLENZ CORPH-0784-2026May be under-processed resulting in growth of Clostridium botulinum and lists health claims.Environmental Monitoring
2026-05-27Class IILIQUID BLENZ CORPH-0793-2026May be under-processed resulting in growth of Clostridium botulinum and lists health claims.Environmental Monitoring
2026-05-27Class IIMedtronic Perfusion SystemsZ-2215-2026Certain lots of product have the potential for a sterile barrier breach.Environmental Monitoring
2026-05-27Class IIWellnov Supplements LLCH-0795-2026Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen contamination and possible C. Botulinum concerns.Environmental Monitoring
2026-05-27Class IILIQUID BLENZ CORPH-0782-2026May be under-processed resulting in growth of Clostridium botulinum and lists health claims.Environmental Monitoring
2026-05-27Class IILIQUID BLENZ CORPH-0785-2026May be under-processed resulting in growth of Clostridium botulinum and lists health claims.Environmental Monitoring
2026-05-27Class IIPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2227-2026The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.Validation & Qualification
2026-05-27Class ISolina U.S. HoldingH-0828-2026potential to be contaminated with SalmonellaEnvironmental Monitoring
2026-05-27Class IIWellnov Supplements LLCH-0798-2026Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.Environmental Monitoring
2026-05-27Class IILIQUID BLENZ CORPH-0794-2026May be under-processed resulting in growth of Clostridium botulinum and lists health claims.Environmental Monitoring
2026-05-27Class IIWellnov Supplements LLCH-0797-2026Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.Environmental Monitoring
2026-05-27Class IIIGolden State Medical Supply Inc.D-0534-2026Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.Environmental Monitoring
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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.