[ 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.

3,493 matching recalls

Date	Class	Firm	Reason	Quality domain
2026-07-15	Class I	Adams Extract & Spice LLCH-1139-2026	Undeclared Sesame allergen	Documentation & Change Control
2026-07-15	Class I	Fresh & Ready Foods LLCH-1149-2026	Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella.	Environmental Monitoring
2026-07-15	Class I	Adams Extract & Spice LLCH-1141-2026	Undeclared Sesame allergen	Documentation & Change Control
2026-07-15	Class II	Specialty Bakers, LLCH-1145-2026	Undeclared Allergen (Soy)	Documentation & Change Control
2026-07-15	Class II	Wise Foods IncH-1146-2026	The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.	Documentation & Change Control
2026-07-15	Class I	Adams Extract & Spice LLCH-1140-2026	Undeclared Sesame allergen	Documentation & Change Control
2026-07-15	Class II	Bear Stewart CoH-1143-2026	undeclared soy	Documentation & Change Control
2026-07-15	Class I	Adams Extract & Spice LLCH-1138-2026	Undeclared Sesame allergen	Documentation & Change Control
2026-07-15	Class II	QuVa Pharma, Inc.D-0664-2026	Failed Impurities/Degradation Specifications	Validation & Qualification
2026-07-15	Class II	Wondermade LLCH-1147-2026	Foreign material: small metal pieces	Environmental Monitoring
2026-07-15	Class II	Gasco Industrial Corp.D-0669-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	Reliance Life Sciences Private LimitedD-0674-2026	Lack of Sterility Assurance	Environmental Monitoring
2026-07-15	Class II	Reliance Life Sciences Private LimitedD-0671-2026	Lack of Sterility Assurance	Environmental Monitoring
2026-07-15	Class II	Reliance Life Sciences Private LimitedD-0673-2026	Lack of Sterility Assurance	Environmental Monitoring
2026-07-15	Class II	Gasco Industrial Corp.D-0668-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	Reliance Life Sciences Private LimitedD-0672-2026	Lack of Sterility Assurance	Environmental Monitoring
2026-07-15	Class II	Shimoga ChemicalsD-0691-2026	cGMP deviations	Risk Management & CAPA
2026-07-15	Class II	Medline Industries, LPZ-2695-2026	Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.	Risk Management & CAPA
2026-07-15	Class II	Gasco Industrial Corp.D-0670-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	Gasco Industrial Corp.D-0667-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	Gasco Industrial Corp.D-0666-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	Elekta, Inc.Z-2711-2026	Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.	—
2026-07-15	Class II	BioMed Laboratories, LLC.D-0663-2026	Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.	Validation & Qualification
2026-07-15	Class II	Gasco Industrial Corp.D-0665-2026	Subpotent drug	Validation & Qualification
2026-07-15	Class II	ONESOURCE SPECIALTY PHARMA LIMITEDD-0662-2026	Failed Impurities/Degradation Specifications	Validation & Qualification

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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.