Zonisamide recalls
The FDA has published 11 recalls involving Zonisamide since 2014. The latest was reported on 1 Jun 2022. Most were for manufacturing (cgmp) deviations. Glenmark Pharmaceuticals Inc., U 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 2014
Last 12 months 0 reported
Class I 0 0% of total
Ongoing 0 latest 1 Jun 2022
Recalls per month, last 24 months click a bar for that month Severity split
0 0%11 100%0 0%
Why zonisamide is recalled
All zonisamide recalls, newest first 11 total Reported Class Recall Company Reason Where 1 Jun 2022 Drug CLASS II Zonisamide Capsules USP, 100 mg recalled by Direct Rx Direct Rx Manufacturing (CGMP) Deviations Nationwide 4 May 2022 Drug CLASS II Zonisamide Capsules, USP, 100 mg recalled by Glenmark Pharmaceuticals Zonisamide Glenmark Pharmaceuticals Inc., U Manufacturing (CGMP) Deviations Nationwide 4 May 2022 Drug CLASS II Zonisamide Capsules USP, 25 mg recalled by Glenmark Pharmaceuticals Zonisamide Glenmark Pharmaceuticals Inc., U Manufacturing (CGMP) Deviations Nationwide 4 May 2022 Drug CLASS II Zonisamide Capsules, USP, 50 mg recalled by Glenmark Pharmaceuticals Zonisamide Glenmark Pharmaceuticals Inc., U Manufacturing (CGMP) Deviations Nationwide 29 Sep 2021 Drug CLASS II Zonisamide Capsules USP 100 mg recalled by Glenmark Pharmaceuticals Zonisamide Glenmark Pharmaceuticals Inc., U Manufacturing (CGMP) Deviations Nationwide 29 Sep 2021 Drug CLASS II Zonisamide Capsules USP 50 mg recalled by Glenmark Pharmaceuticals Zonisamide Glenmark Pharmaceuticals Inc., U Manufacturing (CGMP) Deviations Nationwide 29 Jul 2015 Drug CLASS II Zonisamide Capsules recalled by Wockhardt Usa Wockhardt Usa Manufacturing (CGMP) Deviations Nationwide 29 Jul 2015 Drug CLASS II Zonisamide Capsules recalled by Wockhardt Usa Wockhardt Usa Manufacturing (CGMP) Deviations Nationwide 29 Jul 2015 Drug CLASS II Zonisamide Capsules recalled by Wockhardt Usa Wockhardt Usa Manufacturing (CGMP) Deviations Nationwide 15 Jul 2015 Drug CLASS II Zonisamide capsules, USP 100mg recalled by American Health Packaging American Health Packaging Manufacturing (CGMP) Deviations Nationwide
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Should you stop taking Zonisamide?
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.