[ 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.

1,475 matching recalls

Date	Class	Firm	Reason	Quality domain
2026-01-14	Class II	Rovira Biscuit CorporationH-0362-2026	Undeclared colors FD&C Yellow #6, and FD&C Red 40	Documentation & Change Control
2026-01-14	Class I	Ambriola Co., Inc., TheH-0368-2026	Product tested positive for Listeria Monocytogenes.	Environmental Monitoring
2026-01-14	Class II	Rovira Biscuit CorporationH-0363-2026	Undeclared colors FD&C Yellow #6, and FD&C Red 40	Documentation & Change Control
2026-01-14	Class I	Ambriola Co., Inc., TheH-0374-2026	Product tested positive for Listeria Monocytogenes.	Environmental Monitoring
2026-01-14	Class II	DIRECT SOURCE SEAFOOD LLCH-0379-2026	Shrimp may be contaminated with Cesium-137 (Cs-137).	Environmental Monitoring
2026-01-07	Class II	Tom Bumble LLCH-0391-2026	Foreign material.	Environmental Monitoring
2026-01-07	Class III	Bendon PublishingH-0350-2026	Unapproved color additive - chlorophyllin copper complex	Documentation & Change Control
2026-01-07	Class II	INDIAN COOKWARE AND APPLIANCE LLCH-0349-2026	Potential contamination due to leachable lead.	Environmental Monitoring
2025-12-31	Class II	Karabetian Import and Distribution, Inc.H-0332-2026	partially hydrogenated oils (PHOs) in foods exported to the US	—
2025-12-31	Class II	Karabetian Import and Distribution, Inc.H-0331-2026	partially hydrogenated oils (PHOs) in foods exported to the US	—
2025-12-31	Class II	Mondelez Global LlcH-0329-2026	Undeclared allergens (Peanut) due to mispackaging	Documentation & Change Control
2025-12-31	Class I	Wegmans Food Markets, Inc.H-0333-2026	Product may be contaminated with Listeria monocytogenes.	Environmental Monitoring
2025-12-31	Class II	The James Skinner LLCH-0330-2026	Undeclared allergen - walnuts. Maple Walnut Coffee Cake was incorrectly labeled as Raspberry Coffee Cake and walnuts were not declared on the label.	Documentation & Change Control
2025-12-31	Class II	First & Last TavernH-0336-2026	May be contaminated with Clostridium botulinum	Environmental Monitoring
2025-12-31	Class II	First & Last TavernH-0335-2026	May be contaminated with Clostridium botulinum	Environmental Monitoring
2025-12-31	Class II	A New Life Herbs, LLCH-0348-2026	Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label	Documentation & Change Control
2025-12-31	Class II	A New Life Herbs, LLCH-0340-2026	Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label	Documentation & Change Control
2025-12-31	Class I	Silvestri Sweets Inc dba Carousel CandiesH-0338-2026	Undeclared wheat	Documentation & Change Control
2025-12-31	Class II	Bell Industries LLCH-0327-2026	Potential Salmonella contamination	Environmental Monitoring
2025-12-31	Class II	A New Life Herbs, LLCH-0345-2026	Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label	Documentation & Change Control
2025-12-31	Class II	Lil Turtles LLCH-0326-2026	Undeclared allergen - milk	Documentation & Change Control
2025-12-31	Class II	A New Life Herbs, LLCH-0347-2026	Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label	Documentation & Change Control
2025-12-31	Class II	A New Life Herbs, LLCH-0343-2026	Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label	Documentation & Change Control
2025-12-31	Class I	Silvestri Sweets Inc dba Carousel CandiesH-0339-2026	Undeclared pecan	Documentation & Change Control
2025-12-31	Class II	First & Last TavernH-0334-2026	May be contaminated with Clostridium botulinum	Environmental Monitoring

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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.