[ 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
214
Class I (most serious)
167
Drug
520
Device
313
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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1,475 matching recalls
DateClassFirmReasonQuality domain
2025-09-10Class IIEvergreen Orchard Farm, LLCH-0556-2025Lack of pasteurization and sanitation records—
2025-09-10Class IIJessie Lord Bakery, LLCH-0568-2025Undeclared Yellow#5 in Lemon Meringue PieDocumentation & Change Control
2025-09-10Class IIHans Kissle Company, LLCH-0558-2025Contains undeclared wheat. The top label identifies the product as potato salad, but the unit contains pasta salad.Documentation & Change Control
2025-09-10Class IIThe Candy BarnH-0564-2025Allergen labeling: specific tree nut (pecan) and egg not listed in 'contains' statementDocumentation & Change Control
2025-09-10Class IIDollins Pecan Co, IncH-0550-2025Undeclared wheat allergen.Documentation & Change Control
2025-09-03Class IIBlue Bell Creameries, L.P.H-0546-2025undeclared almond, walnut, and pecan.Documentation & Change Control
2025-09-03Class ICHETAK NEW YORK LLCH-0574-2025Product tested positive Salmonella .Environmental Monitoring
2025-09-03Class IIGelsonsH-0526-2025Gelson branded Hummus product labels do not include storage instructions "keep refrigerated"Documentation & Change Control
2025-09-03Class IIH & N Group Inc.H-0548-2025Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)Environmental Monitoring
2025-09-03Class IIBakers Authority LLCH-0533-2025Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: millet and flaxDocumentation & Change Control
2025-09-03Class IIThe J.M. Smucker CompanyH-0577-2025Mold. The firm noticed an increase in customer complaints. They conducted a root cause investigation and discovered that one of their coolers had malfunctioning.Environmental Monitoring
2025-09-03Class IIDFA Dairy Brands, LLCH-0537-2025Product contains undeclared wheat and soy.Documentation & Change Control
2025-09-03Class IIBakers Authority LLCH-0534-2025Product label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: poppy seeds, dried garlic, dried onion, and sea saltDocumentation & Change Control
2025-09-03Class IMiddlefield Original Cheese CooperativeH-0528-2025Potential contamination with Listeria monocytogenesEnvironmental Monitoring
2025-09-03Class IMiddlefield Original Cheese CooperativeH-0530-2025Potential contamination with Listeria monocytogenesEnvironmental Monitoring
2025-09-03Class IIBakers Authority LLCH-0535-2025Product label does not list ingredients including major food allergens: wheat and soy (vegetable oil). Additional undeclared ingredients include: niacin, reduced iron, vitamin B1, vitamin B2, invert sugarDocumentation & Change Control
2025-09-03Class IIGelsonsH-0524-2025Gelson branded Hummus product labels do not include storage instructions "keep refrigerated"Documentation & Change Control
2025-09-03Class IIBreadbox Co.H-0531-2025Finished product label does not include allergen ingredient Sesame Seed.Documentation & Change Control
2025-09-03Class INEW ACAI AMAZONAS LLCH-0538-2025Potential Salmonella contaminationEnvironmental Monitoring
2025-09-03Class IIGelsonsH-0525-2025Gelson branded Hummus product labels do not include storage instructions "keep refrigerated"Documentation & Change Control
2025-09-03Class IMiddlefield Original Cheese CooperativeH-0527-2025Potential contamination with Listeria monocytogenesEnvironmental Monitoring
2025-09-03Class IFromi UsaH-0547-2025Product may be contaminated with Listeria monocytogenesEnvironmental Monitoring
2025-09-03Class IIGelsonsH-0523-2025Gelson branded Tzatziki sauce product labels do not include storage instructions "keep refrigerated"Documentation & Change Control
2025-09-03Class IIMartin Bauer, Inc.H-0532-2025Misbranding of the ingredient the firm sells ( Passionflower Herb Extract )Documentation & Change Control
2025-09-03Class ICHETAK NEW YORK LLCH-0575-2025Product tested positive Salmonella .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.