[ 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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758 matching recalls
DateClassFirmReasonQuality domain
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
2026-06-03Class IIMedtronic NeuromodulationZ-2240-2026A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.Documentation & Change Control
2026-06-03Class IIMedtronic NeuromodulationZ-2241-2026A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.Documentation & Change Control
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 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 IWawa Beverage CompanyH-0857-2026Undeclared Milk Allergen,Documentation & Change Control
2026-06-03Class IWawa Beverage CompanyH-0856-2026Undeclared Milk Allergen,Documentation & Change Control
2026-05-27Class IIHaleon US Holdings LLCD-0542-2026Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.Documentation & Change Control
2026-05-27Class IISafecor Health, LLCD-0538-2026Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.Documentation & Change Control
2026-05-20Class IIProspector Popcorn, LLCH-0779-2026Products contain undeclared soy, specifically soy lecithin.Documentation & Change Control
2026-05-20Class IIWE R NUTSH-0775-2026Contains undeclared allergens (cashews, milk, and soy).Documentation & Change Control
2026-05-20Class IIRaja Foods and Vegetables Inc.H-0778-2026Contains undeclared Blue 1Documentation & Change Control
2026-05-20Class IIFerris Coffee and Nut Company, Inc.H-0774-2026Undeclared allergens (wheat and soy).Documentation & Change Control
2026-05-20Class IIEdwards Lifesciences, LLCZ-2172-2026Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.Documentation & Change Control
2026-05-20Class IIAniara Diagnostica LLCZ-2171-2026Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.Documentation & Change Control
2026-05-20Class IOmnicell, Inc.Z-2047-2026Potential for mislabeled syringe produced by the i.v.STATION device.Documentation & Change Control
2026-05-20Class IIOcinet, Inc.H-0780-2026Undeclared allergen ingredient (fish)Documentation & Change Control
2026-05-20Class IIMICROVENTION INC.Z-2200-2026Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological eventsDocumentation & Change Control
2026-05-20Class IIRaja Foods and Vegetables Inc.H-0777-2026Contains undeclared FD&C Yellow 6Documentation & Change Control
2026-05-13Class IIHorizon Organic Dairy, LLCH-0711-2026Package integrity compromised.Documentation & Change Control
2026-05-13Class IIDisaronno Ingredients S.p.a.H-0690-2026Undeclared allergen Milk. The presence of the milk allergen in the product was found to exceed acceptable levels despite the product being labeled with the statement *May contain milk. *Documentation & Change Control
2026-05-13Class IISilver Moon LP dba Loard's Ice CreamH-0713-2026Undeclared Milk, Almonds, Soy, Sulfites.Documentation & Change Control
2026-05-13Class IISilver Moon LP dba Loard's Ice CreamH-0716-2026Undeclared Milk, Red #40, Blue #1.Documentation & Change Control
2026-05-13Class IISilver Moon LP dba Loard's Ice CreamH-0724-2026Undeclared Milk, Red #40.Documentation & 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.