[ 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
758 matching recalls
DateClassFirmReasonQuality domain
2026-03-18Class IICocos Wholesale and Imports, LLCH-0553-2026Label lists semolina and durum flour as sub-ingredients of the pasta, but does not declare wheatDocumentation & Change Control
2026-03-18Class IIITipp Distributors, Inc. dba NovamexH-0545-2026The outer cardboard box for the canned coconut water has the incorrect Nutrition Facts Panel and Ingredient List, which does not include added sugar (5g per 17.5oz can), while the primary packaging (the can) has the correct Nutrition Facts Panel and Ingredient List.Documentation & Change Control
2026-03-11Class IStuffbyNainaxD-0397-2026Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafilDocumentation & Change Control
2026-03-11Class IIBader Enterprises, Inc.H-0538-2026Contains undeclared allergen (wheat) and colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).Documentation & Change Control
2026-03-11Class IPerfect Pasta, IncorporatedH-0620-2026Undeclared shrimp, crab, lobster, pollock (fish), whiting (fish), and soy.Documentation & Change Control
2026-03-11Class IANTHONY TRINH, 123Herbals LLCD-0388-2026Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.Documentation & Change Control
2026-03-11Class IIBader Enterprises, Inc.H-0539-2026Contains undeclared colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).Documentation & Change Control
2026-03-11Class IJuniper Granola, LLCH-0543-2026Products contain undeclared milk and soy.Documentation & Change Control
2026-03-11Class IJuniper Granola, LLCH-0542-2026Products contain undeclared milk and soy.Documentation & Change Control
2026-03-11Class IKarns Prime And Fancy FoodsH-0574-2026Product may contain undeclared peanuts.Documentation & Change Control
2026-03-11Class IMohamed HagarD-0396-2026Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).Documentation & Change Control
2026-03-11Class IIThe Harvard Drug Group LLCD-0383-2026Defective container; inadequately sealed blister packaging.Documentation & Change Control
2026-03-04Class IIAgeboxD-0345-2026Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamorenDocumentation & Change Control
2026-03-04Class IIITENGEN USA TRADING CORPH-0525-2026Product contains undeclared cyclamates.Documentation & Change Control
2026-03-04Class IMIN JIANG FOOD STORE INC DBA KOI KOI TRADINGH-0531-2026Undeclared allergen ingredient (Wheat and Sesame)Documentation & Change Control
2026-03-04Class IMIN JIANG FOOD STORE INC DBA KOI KOI TRADINGH-0532-2026Undeclared allergen ingredient (Wheat and Sesame)Documentation & Change Control
2026-03-04Class IIISlate Run PharmaceuticalsD-0343-2026Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.Documentation & Change Control
2026-03-04Class IMIN JIANG FOOD STORE INC DBA KOI KOI TRADINGH-0530-2026Undeclared allergen ingredient (Wheat and Sesame)Documentation & Change Control
2026-03-04Class IIAgeboxD-0344-2026Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamorenDocumentation & Change Control
2026-03-04Class IIITENGEN USA TRADING CORPH-0526-2026Product contains undeclared cyclamates.Documentation & Change Control
2026-02-25Class IIPure Solutions, Inc.H-0537-2026Label declares bovine colostrum but does not declare milk allergen.Documentation & Change Control
2026-02-25Class IReser's Fine Foods, Inc.H-0517-2026Undeclared fish allergen (tuna). Tuna Salad was mislabeled as Chicken Salad.Documentation & Change Control
2026-02-18Class IIISLAND CRAB CORPORATIONH-0494-2026Undeclared Milk, Eggs, Sodium metabisulfiteDocumentation & Change Control
2026-02-18Class IIKarison Foods & Snacks, Inc.H-0507-2026Product contains milk, which is undeclared in the ingredient statement.Documentation & Change Control
2026-02-18Class ICostco Wholesale CorporationH-0491-2026Undeclared hazelnut.Documentation & Change Control
Page 16 of 31
← 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.