[ 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
2026-07-22Class IIOrthofix U.S. LLCZ-2729-2026Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111Documentation & Change Control
2026-07-15Class IIKlowen BracesZ-2699-2026A product error defect may cause incorrect bracket placement.Documentation & Change Control
2026-07-15Class IIEncore Medical, LPZ-2701-2026Due to packaging discrepancy with incorrect product size mixed up.Documentation & Change Control
2026-07-15Class IAdams Extract & Spice LLCH-1140-2026Undeclared Sesame allergenDocumentation & Change Control
2026-07-15Class IISpecialty Bakers, LLCH-1145-2026Undeclared Allergen (Soy)Documentation & Change Control
2026-07-15Class IIWise Foods IncH-1146-2026The product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3.Documentation & Change Control
2026-07-15Class IIAdams Extract & Spice LLCH-1142-2026Undeclared Sesame allergenDocumentation & Change Control
2026-07-15Class IAdams Extract & Spice LLCH-1138-2026Undeclared Sesame allergenDocumentation & Change Control
2026-07-15Class IIBear Stewart CoH-1143-2026undeclared soyDocumentation & Change Control
2026-07-15Class IAdams Extract & Spice LLCH-1141-2026Undeclared Sesame allergenDocumentation & Change Control
2026-07-15Class IAdams Extract & Spice LLCH-1139-2026Undeclared Sesame allergenDocumentation & Change Control
2026-07-15Class IIEncore Medical, LPZ-2700-2026Due to packaging discrepancy with incorrect product size mixed up.Documentation & Change Control
2026-07-15Class ILehi Valley Trading Company, IncH-1150-2026Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging.Documentation & Change Control
2026-07-08Class IWestern Mixers Produce & Nuts, Inc.H-1125-2026Undeclared peanuts.Documentation & Change Control
2026-07-08Class IICovidien LLCZ-2653-2026Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.Documentation & Change Control
2026-07-08Class IIMasimo CorporationZ-2671-2026Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.Documentation & Change Control
2026-07-08Class IIProvision Health Corp. dba PH LabsH-1135-2026Dietary supplement product Vista MAX contains undeclared Yellow#5.Documentation & Change Control
2026-07-08Class IIFry Pie Factory LLCH-1136-2026Undeclared allergen (milk) and process deviation (product not held under refrigeration as required)Documentation & Change Control
2026-07-08Class IILe Chef Bakeryundeclared colors (yellow#5)Documentation & Change Control
2026-07-08Class IIMasimo CorporationZ-2670-2026Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.Documentation & Change Control
2026-07-08Class IIBD SWITZERLAND SARLZ-2654-2026Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.Documentation & Change Control
2026-07-08Class IILannett Company Inc.D-0660-2026Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.Documentation & Change Control
2026-07-08Class IIBoehringer Ingelheim Pharmaceuticals, Inc.D-0657-2026CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.Documentation & Change Control
2026-07-08Class IIProvision Health Corp. dba PH LabsH-1134-2026Dietary supplement product Ocular Plus contains undeclared Yellow#5.Documentation & Change Control
2026-07-08Class IIMcKessonD-0714-2026Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.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.