[ 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
2026-05-13Class IIMint Medical GmbHZ-2068-2026If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.Documentation & Change Control
2026-05-13Class IISilver Moon LP dba Loard's Ice CreamH-0755-2026Undeclared Milk.Documentation & Change Control
2026-05-13Class IISilver Moon LP dba Loard's Ice CreamH-0749-2026Undeclared Milk, Red #40.Documentation & Change Control
2026-05-13Class IISilver Moon LP dba Loard's Ice CreamH-0720-2026Undeclared Milk, Red #40, Blue #1, Blue #2.Documentation & Change Control
2026-05-13Class IIDFI Co., Ltd.Z-2088-2026The devices were distributed without required FDA premarket clearance or approval.Documentation & Change Control
2026-05-13Class IISilver Moon LP dba Loard's Ice CreamH-0758-2026Undeclared Soy (with mitigating circumstances), Yellow #5, Blue #1Documentation & Change Control
2026-05-13Class IIDFI Co., Ltd.Z-2085-2026The devices were distributed without required FDA premarket clearance or approval.Documentation & Change Control
2026-05-13Class IISilver Moon LP dba Loard's Ice CreamH-0714-2026Undeclared Milk, Yellow #5.Documentation & Change Control
2026-05-13Class IISilver Moon LP dba Loard's Ice CreamH-0715-2026Undeclared Milk, Red #40, Blue #1.Documentation & Change Control
2026-05-06Class IISchreiber Foods IncH-0675-2026Undeclared allergen (almond).Documentation & Change Control
2026-05-06Class IIGuangdong Zonegoing Food Co., LTDH-0676-2026Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).Documentation & Change Control
2026-05-06Class IIGuangdong Zonegoing Food Co., LTDH-0678-2026Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).Documentation & Change Control
2026-05-06Class IIKing Juice Company, Inc.H-0685-2026Product contains undeclared Yellow No. 5.Documentation & Change Control
2026-05-06Class IIGuangdong Zonegoing Food Co., LTDH-0677-2026Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).Documentation & Change Control
2026-05-06Class IIStraumann USA LLCZ-1995-2026Includes an incorrect screw seat interface.Documentation & Change Control
2026-05-06Class IIStraumann USA LLCZ-1994-2026Includes an incorrect screw seat interface.Documentation & Change Control
2026-05-06Class IIHadson (Toko) Trading Co. Inc.H-0679-2026Contains undeclared FD&C Yellow 6Documentation & Change Control
2026-05-06Class IIGanesha Enterprises LLCH-0683-2026Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14.Documentation & Change Control
2026-05-06Class IIIAmerican Regent, Inc.D-0494-2026Labeling: Missing LabelDocumentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1885-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1829-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
2026-04-29Class IIMarquez Brothers International, Inc.H-0672-2026Undeclared milk.Documentation & Change Control
2026-04-29Class IIMarquez Brothers International, Inc.H-0674-2026Undeclared milk.Documentation & Change Control
2026-04-29Class IIMarquez Brothers International, Inc.H-0673-2026Undeclared milk.Documentation & Change Control
2026-04-29Class IIEthnic Foods IncH-0669-2026Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40Documentation & 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.