[ 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-2731-2026Unilateral 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
2026-07-22Class II3B Medical, Inc.Z-2740-2026Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1158-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IIDaavlin Distributing CompanyZ-2743-2026Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1162-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IIOrthofix U.S. LLCZ-2730-2026Unilateral 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
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1164-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1170-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IIDaavlin Distributing CompanyZ-2744-2026Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).Documentation & Change Control
2026-07-22Class IIDaavlin Distributing CompanyZ-2742-2026Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1171-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1169-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1172-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1173-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1168-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1167-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1159-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IIFayus Inc.H-1175-2026Undeclared peanutsDocumentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1165-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IIChocolate Bar Holdings LLCH-1156-2026Undeclared milk allergen.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1161-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1163-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1160-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1166-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
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
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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.