Lamotrigine recalls
The FDA has published 11 recalls involving Lamotrigine since 2013. The latest was reported on 17 Aug 2022. Most were for manufacturing (cgmp) deviations. Avkare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 11 since 2013
Last 12 months 0 reported
Class I 1 9% of total
Ongoing 0 latest 17 Aug 2022
Recalls per month, last 24 months click a bar for that month Severity split
1 9%6 55%4 36%
Why lamotrigine is recalled
All lamotrigine recalls, newest first 11 total Reported Class Recall Company Reason Where 17 Aug 2022 Drug CLASS III Lamotrigine Tablets, USP 100 mg recalled by AVKARE Lamotrigine Avkare Other Nationwide 2 Jun 2021 Drug CLASS II Lamotrigine Extended-Release Tablets 250 mg recalled by Cardinal Health Cardinal Health Manufacturing (CGMP) Deviations FL, GA, SC 10 Jun 2020 Drug CLASS III Lamotrigine Tablets, USP, 150 mg recalled by AVKARE Lamotrigine Avkare Other Nationwide 3 Jun 2020 Drug CLASS III Lamotrigine Tablets, USP, 150 mg bulk container recalled Jubilant Cadista Pharmaceuticals Packaging Defects TN 19 Feb 2020 Drug CLASS I Lamotrigine Tablets, USP, 100 mg recalled by Taro Pharmaceuticals U.S.A Lamotrigine Taro Pharmaceuticals U Other Nationwide 26 Sep 2018 Drug CLASS II Lamotrigine Extended-Release Tablets, USP, 200 mg recalled Lamotrigine Torrent Pharma Potency & Assay Nationwide 5 Oct 2016 Drug CLASS III Lamotrigine Tablets recalled by Unichem Pharmaceuticals Usa Lamotrigine Unichem Pharmaceuticals Usa Other Nationwide 29 Jul 2015 Drug CLASS II Lamotrigine Extended-Release Tablets recalled by Wockhardt Usa Wockhardt Usa Manufacturing (CGMP) Deviations Nationwide 28 Jan 2015 Drug CLASS II Lamotrigine Tablets, 200 mg per blister card x 10 blister recalled Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Manufacturing (CGMP) Deviations Nationwide 22 Jan 2014 Drug CLASS II lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg) recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 13 Nov 2013 Drug CLASS II Lamotrigine Tablets, USP, 200 mg recalled by Mylan Pharmaceuticals Mylan Pharmaceuticals Manufacturing (CGMP) Deviations Nationwide
Should you stop taking Lamotrigine?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.