[ 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
2026-06-03Class ILegacy Bakehouse LLCH-0850-2026Products were made with recalled California Dairies milk powder due to Salmonella.Environmental Monitoring
2026-06-03Class IIIAbbVie Inc.D-0551-2026Failed Stability SpecificationsValidation & Qualification
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 IBolton Medical Inc.Z-2160-2026Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.Documentation & Change Control
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-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 IIGE Medical Systems Information Technologies IncZ-2247-2026GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).—
2026-06-03Class IAbiomed, Inc.Z-2238-2026Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.—
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-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 IIGE Medical Systems Information Technologies IncZ-2246-2026GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).—
2026-06-03Class IIFly By Jing Inc.H-0854-2026Possible cross-contamination resulting in undeclared allergen ingredient (Peanut)Environmental Monitoring
2026-06-03Class IWawa Beverage CompanyH-0858-2026Undeclared Milk Allergen,Documentation & Change Control
2026-06-03Class IWawa Beverage CompanyH-0855-2026Undeclared Milk Allergen,Documentation & Change Control
2026-06-03Class ILegacy Bakehouse LLCH-0851-2026Products were made with recalled California Dairies milk powder due to Salmonella.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 ILegacy Bakehouse LLCH-0852-2026Products 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 IWawa Beverage CompanyH-0857-2026Undeclared Milk Allergen,Documentation & Change Control
2026-06-03Class IIPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2259-2026It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.—
2026-06-03Class IWawa Beverage CompanyH-0856-2026Undeclared Milk Allergen,Documentation & Change Control
2026-06-03Class IIIAVEVA Drug Delivery Systems, Inc.D-0550-2026Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.Validation & Qualification
2026-06-03Class IIDevicor Medical Products IncZ-2239-2026Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.Documentation & Change Control
2026-05-27Class IIIntegraDose Compounding Services LLCD-0548-2026Subpotent DrugValidation & Qualification
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.