[ 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.

Reset
1,232 matching recalls
DateClassFirmReasonQuality domain
2025-09-24Class IPRIMO NO. 1 IN PRODUCE, INCH-0606-2025Product contaminated with SalmonellaEnvironmental Monitoring
2025-09-24Class IIAdmiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0584-2025Product may be contaminated with Cesium-137 (Cs-137).Environmental Monitoring
2025-09-24Class IIAdmiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0583-2025Product may be contaminated with Cesium-137 (Cs-137).Environmental Monitoring
2025-09-24Class IIHARD EIGHT NUTRITION LLCH-0619-2025Finished product possibly contaminated with pathogenic Staphylococcus aureus.Environmental Monitoring
2025-09-24Class IISouthwind Foods LLC dba Great American Seafood Imports Co.H-0603-2025Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)Environmental Monitoring
2025-09-24Class IPRIMO NO. 1 IN PRODUCE, INCH-0607-2025Product contaminated with SalmonellaEnvironmental Monitoring
2025-09-24Class IPRIMO NO. 1 IN PRODUCE, INCH-0610-2025Product contaminated with SalmonellaEnvironmental Monitoring
2025-09-24Class IPRIMO NO. 1 IN PRODUCE, INCH-0608-2025Product contaminated with SalmonellaEnvironmental Monitoring
2025-09-24Class IPRIMO NO. 1 IN PRODUCE, INCH-0609-2025Product contaminated with SalmonellaEnvironmental Monitoring
2025-09-24Class IEndico Potatoes IncH-0618-2025Product may be contaminated with Listeria monocytogenes.Environmental Monitoring
2025-09-17Class IWegmans Food Markets, Inc.H-0569-2025Products may be contaminated with Listeria monocytogenesEnvironmental Monitoring
2025-09-17Class IWegmans Food Markets, Inc.H-0570-2025Products may be contaminated with Listeria monocytogenesEnvironmental Monitoring
2025-09-17Class IWegmans Food Markets, Inc.H-0572-2025Products may be contaminated with Listeria monocytogenesEnvironmental Monitoring
2025-09-17Class IIM.O.M Enterprises, LLC.H-0576-2025Potential for spoilage due to yeast contamination.Environmental Monitoring
2025-09-17Class IWegmans Food Markets, Inc.H-0571-2025Products may be contaminated with Listeria monocytogenesEnvironmental Monitoring
2025-09-17Class IIHERSHEY CREAMERY CO.H-0579-2025Product tested elevated coliform counts during routine testingEnvironmental Monitoring
2025-09-10Class IITAMPA MAID FOODS, LLCH-0553-2025Product may be contaminated with Cesium-137 (Cs-137)Environmental Monitoring
2025-09-10Class IITAMPA MAID FOODS, LLCH-0552-2025Product may be contaminated with Cesium-137 (Cs-137)Environmental Monitoring
2025-09-10Class IDermaRite Industries, LLCD-0612-2025Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.Environmental Monitoring
2025-09-10Class IITAMPA MAID FOODS, LLCH-0551-2025Product may be contaminated with Cesium-137 (Cs-137)Environmental Monitoring
2025-09-10Class IDermaRite Industries, LLCD-0610-2025Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.Environmental Monitoring
2025-09-10Class IB BRAUN MEDICAL INCD-0627-2025Presence of Particulate MatterEnvironmental Monitoring
2025-09-10Class IDermaRite Industries, LLCD-0611-2025Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.Environmental Monitoring
2025-09-10Class IB BRAUN MEDICAL INCD-0628-2025Presence of Particulate Matter.Environmental Monitoring
2025-09-10Class IDermaRite Industries, LLCD-0613-2025Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.Environmental Monitoring
Page 46 of 50
← PrevNext →

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.