[ 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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1,496 matching recalls
DateClassFirmReasonQuality domain
2026-03-25Class IIWawa Beverage CompanyH-0588-2026Foreign plastic material discovered on fill line.—
2026-03-25Class IShaman Botanicals, LLCH-1107-2026A sample of the product had the active ingredient in a quantity greater than the labeled specification.Documentation & Change Control
2026-03-25Class IFRITO-LAY NORTH AMERICA, INC.H-0571-2026Undeclared Allergen: MilkDocumentation & Change Control
2026-03-25Class IISAPUTO CHEESE USA, INCH-0579-2026Potentially under pasteurized. The firm was notified by the California Department of Agriculture that due to the broken seal on the pasteurizer, the products may be under pasteurized, and they should recall the products.—
2026-03-25Class IBluegrass Ingredients Inc.H-0572-2026Potential Salmonella contaminationEnvironmental Monitoring
2026-03-25Class IKradjian Importing Company, Inc.H-0576-2026Undeclared allergen ingredients (sesame and wheat) in Zaatar Spice mix.Documentation & Change Control
2026-03-25Class IDreamland IncH-0575-2026Undeclared Sesame, Soy, WheatDocumentation & Change Control
2026-03-25Class IIWawa Beverage CompanyH-0586-2026Foreign plastic material discovered on fill line.—
2026-03-25Class IIIWinder Laboratories, LLCH-0569-2026Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.Validation & Qualification
2026-03-25Class IIBlueFrog FoodsH-0578-2026No process authorityRisk Management & CAPA
2026-03-18Class IIWillamette Valley Pie Company, LLCH-0550-2026Potential contamination with listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0555-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0563-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IIPalmetto Gourmet Foods Inc.H-0547-2026Product contains undeclared Yellow #5Documentation & Change Control
2026-03-18Class IMade Fresh Salads IncH-0565-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0557-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
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
2026-03-18Class IMade Fresh Salads IncH-0559-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0566-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0560-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IIPolski Ogrod Sp. z o.o.H-0549-2026potential contamination with glassEnvironmental Monitoring
2026-03-18Class IAmbrosia Brands LLCH-0546-2026Product may be contaminated with SalmonellaEnvironmental Monitoring
2026-03-18Class IICocos Wholesale and Imports, LLCH-0554-2026Label lists flour as a sub-ingredient of the shells, and ricotta cheese as a sub-ingredient of the cream but does not declare wheat or milk.Documentation & Change Control
2026-03-18Class IIPalmetto Gourmet Foods Inc.H-0548-2026Product contains undeclared Yellow #5Documentation & Change Control
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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.