[ 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.

Reset
758 matching recalls
DateClassFirmReasonQuality domain
2025-12-31Class IIThe James Skinner LLCH-0330-2026Undeclared allergen - walnuts. Maple Walnut Coffee Cake was incorrectly labeled as Raspberry Coffee Cake and walnuts were not declared on the label.Documentation & Change Control
2025-12-31Class IIA New Life Herbs, LLCH-0346-2026Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts labelDocumentation & Change Control
2025-12-31Class IIA New Life Herbs, LLCH-0344-2026Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts labelDocumentation & Change Control
2025-12-31Class IIMondelez Global LlcH-0329-2026Undeclared allergens (Peanut) due to mispackagingDocumentation & Change Control
2025-12-31Class IIA New Life Herbs, LLCH-0348-2026Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts labelDocumentation & Change Control
2025-12-31Class IIA New Life Herbs, LLCH-0340-2026Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts labelDocumentation & Change Control
2025-12-31Class ISilvestri Sweets Inc dba Carousel CandiesH-0338-2026Undeclared wheatDocumentation & Change Control
2025-12-31Class IIA New Life Herbs, LLCH-0345-2026Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts labelDocumentation & Change Control
2025-12-31Class IILil Turtles LLCH-0326-2026Undeclared allergen - milkDocumentation & Change Control
2025-12-31Class IIA New Life Herbs, LLCH-0343-2026Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts labelDocumentation & Change Control
2025-12-31Class ISilvestri Sweets Inc dba Carousel CandiesH-0339-2026Undeclared pecanDocumentation & Change Control
2025-12-31Class IIA New Life Herbs, LLCH-0342-2026Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts labelDocumentation & Change Control
2025-12-31Class IIA New Life Herbs, LLCH-0341-2026Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts labelDocumentation & Change Control
2025-12-24Class IIDough-To-Go IncH-0364-2026Undeclared Milk and FD&C Blue #1.Documentation & Change Control
2025-12-24Class IIPreferred Pharmaceuticals, Inc.D-0239-2026Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.Documentation & Change Control
2025-12-17Class IIIWinder Laboratories, LLCD-0223-2026Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.Documentation & Change Control
2025-12-17Class IIFagron Compounding ServicesD-0221-2026Incorrect Product FormulationDocumentation & Change Control
2025-12-17Class IIGimme Coffee, Inc.H-0303-2026Undeclared caffeineDocumentation & Change Control
2025-12-17Class IIIKosher First LLCH-0238-2026Undeclared FD&C Red #40Documentation & Change Control
2025-12-17Class IStuffed Foods LLCH-0246-2026Undeclared Soy Protein ConcentrateDocumentation & Change Control
2025-12-10Class IGenepro Protein, Inc.H-0302-2026Product is mislabeled - the labeling contains incorrect ingredient information and fails to declare milk as an allergenDocumentation & Change Control
2025-12-10Class IIBlonde Beard'sH-0223-2026Undeclared SoyDocumentation & Change Control
2025-12-10Class IIIPacific Seafood - Portland, LLCH-0226-2026Undeclared Sulfite. Shrimp may contain 3.4mg Sulfur Dioxide per serving and label does not declare Sulfite.Documentation & Change Control
2025-12-10Class IIRong Shing Trading NY IncH-0247-2026Product contains undeclared sulfites (7.39mg/serving) and cyclamatesDocumentation & Change Control
2025-12-10Class IIIAvion Pharmaceuticals, LLCH-0233-2026Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.Documentation & Change Control
Page 20 of 31
← PrevNext →

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.