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Lamotrigine

FDA recalls

5 rows

DateCompany and reasonClass
Jul 19, 2022Avkare Inc.
Labeling: Label Error on Declared Strength		Class III · Terminated
May 27, 2020Avkare Inc.
Presence of Foreign Substance consistent with granules from desiccant packs used during storage		Class III · Terminated
Dec 19, 2019Taro Pharmaceuticals U.S.A., Inc.
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.		Class I · Terminated
Sep 10, 2018Torrent Pharma Inc.
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.		Class II · Terminated
Aug 18, 2016Unichem Pharmaceuticals Usa Inc
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.		Class III · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).