[ 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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1,235 matching recalls
DateClassFirmReasonQuality domain
2026-06-10Class IJCB Flavors, LLCH-0890-2026Products may be potentially contaminated with Salmonella.Environmental Monitoring
2026-06-10Class IIStraus Family CreameryH-0897-2026Potential contamination with foreign objects (metal pieces).Environmental Monitoring
2026-06-10Class IThe Coffee Connexion Co., IncH-0908-2026Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contaminationEnvironmental Monitoring
2026-06-10Class ISKS Copackfood-20260610-SKS CopackProducts may potentially be contaminated with Salmonella.Environmental Monitoring
2026-06-10Class INassar Investment Company LLCH-0860-2026Salmonella. The firm was notified by the North Carolina Department of Agriculture that the product test positive for Salmonella.Environmental Monitoring
2026-06-10Class ITerra Medi LLCH-0899-2026Un-eviscerated fish may be contaminated with clostridium botulinumEnvironmental Monitoring
2026-06-10Class IJCB Flavors, LLCH-0886-2026Products may be potentially contaminated with Salmonella.Environmental Monitoring
2026-06-03Class IMedline Industries, LPZ-2231-2026Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.Environmental Monitoring
2026-06-03Class IMedline Industries, LPZ-2237-2026Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.Environmental Monitoring
2026-06-03Class IMedline Industries, LPZ-2235-2026Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.Environmental Monitoring
2026-06-03Class IMedline Industries, LPZ-2233-2026Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.Environmental Monitoring
2026-06-03Class IIMedline Industries, LPZ-2260-2026Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the syringes inside are U-100 insulin syringes.Environmental Monitoring
2026-06-03Class IMedline Industries, LPZ-2234-2026Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.Environmental Monitoring
2026-06-03Class IMedline Industries, LPZ-2236-2026Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.Environmental Monitoring
2026-06-03Class IMedline Industries, LPZ-2232-2026Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints.Environmental Monitoring
2026-06-03Class IIFly By Jing Inc.H-0854-2026Possible cross-contamination resulting in undeclared allergen ingredient (Peanut)Environmental Monitoring
2026-06-03Class ILegacy Bakehouse LLCH-0851-2026Products were made with recalled California Dairies milk powder due to Salmonella.Environmental Monitoring
2026-06-03Class IHoneyville, IncH-0849-2026Firm received and used potentially contaminated (Salmonella) ingredient to manufacture various products.Environmental Monitoring
2026-06-03Class ILegacy Bakehouse LLCH-0852-2026Products were made with recalled California Dairies milk powder due to Salmonella.Environmental Monitoring
2026-06-03Class ILegacy Bakehouse LLCH-0850-2026Products were made with recalled California Dairies milk powder due to Salmonella.Environmental Monitoring
2026-05-27Class IIIAmerisource Health Services LLCD-0536-2026Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.Environmental Monitoring
2026-05-27Class IIWellnov Supplements LLCH-0803-2026Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.Environmental Monitoring
2026-05-27Class IIWellnov Supplements LLCH-0800-2026Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.Environmental Monitoring
2026-05-27Class IIUCB Biosciences Inc.D-0546-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-05-27Class IILlorens Pharmaceuticals International Division, Inc.H-0809-2026Foreign object: black particulate matterEnvironmental 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.