CLASS II Drug recall · Reported 29 Sep 2021 · FDA Enforcement Report

Zonisamide Capsules USP 100 mg recalled by Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Inc., U is recalling Zonisamide Capsules USP 100 mg, distributed nationwide in the US. The recall was initiated on 27 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: a) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023; 29200030 Exp. 05/31/2023; 29200031 Exp. 05/31/2023; 29200032 Exp. 05/31/2023; 29200033 Exp. 06/30/2023; 29200037 Exp. 06/30/2023; 29200038 Exp. 06/30/2023; 29200039 Exp. 07/31/2023; 29200041 Exp. 07/31/2023; 29200042 Exp. 07/31/2023; 29200048 Exp. 08/31/2023; 29200049 Exp. 08/31/2023; 29200050 Exp. 08/31/2023; 29200072 Exp. 11/30/2023; 29200073 Exp. 11/30/2023; 29200074 Exp. 11/30/2023; 29200075 Exp. 11/30/2023; 29200076 Exp. 11/30/2023; b) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023

NDC68462-128, 68462-129, 68462-130

UPC0368462130018, 0368462129012, 0368462128015

Quantity recalleda) 216,454 bottles; b) 2166 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0826-2021
FDA event ID: 88591
Recalling firm: Glenmark Pharmaceuticals Inc., U, Mahwah, NJ
Brand: Zonisamide
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Classification: Class II
Status: Terminated
Recall initiated: 27 Aug 2021
FDA classified: 21 Sep 2021
Reported: 29 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations

Timeline

27 Aug 2021	Recall initiated by company
21 Sep 2021	Classified by FDA	+25 days
29 Sep 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations

Product as listed by the FDA

Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05

Where it was distributed

Nationwide.

Nationwide

Questions about this recall

Is Zonisamide Capsules USP 100 mg recalled?

Yes. Glenmark Pharmaceuticals Inc., U recalled Zonisamide Capsules USP 100 mg on 27 Aug 2021. The recall is Class II and its status is Terminated. Recall number D-0826-2021.

Why was it recalled?

CGMP Deviations

Which lots are affected?

Lots: a) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023; 29200030 Exp. 05/31/2023; 29200031 Exp. 05/31/2023; 29200032 Exp. 05/31/2023; 29200033 Exp. 06/30/2023; 29200037 Exp. 06/30/2023; 29200038 Exp. 06/30/2023; 29200039 Exp. 07/31/2023; 29200041 Exp. 07/31/2023; 29200042 Exp. 07/31/2023; 29200048 Exp. 08/31/2023; 29200049 Exp. 08/31/2023; 29200050 Exp. 08/31/2023; 29200072 Exp. 11/30/2023; 29200073 Exp. 11/30/2023; 29200074 Exp. 11/30/2023; 29200075 Exp. 11/30/2023; 29200076 Exp. 11/30/2023; b) 29200014 Exp. 02/28/2023; 29200015 Exp. 03/31/2023; 29200016 Exp. 03/31/2023

Where was it sold?

Nationwide.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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All 141

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Other Zonisamide recalls

All 11

Reported	Class	Recall	Company	Reason	Where
1 Jun 2022Drug	CLASS II	Zonisamide Capsules USP, 100 mg recalled by Direct Rx	Direct Rx	Manufacturing (CGMP) Deviations	Nationwide
4 May 2022Drug	CLASS II	Zonisamide Capsules, USP, 100 mg recalled by Glenmark PharmaceuticalsZonisamide	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
4 May 2022Drug	CLASS II	Zonisamide Capsules USP, 25 mg recalled by Glenmark PharmaceuticalsZonisamide	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
4 May 2022Drug	CLASS II	Zonisamide Capsules, USP, 50 mg recalled by Glenmark PharmaceuticalsZonisamide	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide
29 Sep 2021Drug	CLASS II	Zonisamide Capsules USP 50 mg recalled by Glenmark PharmaceuticalsZonisamide	Glenmark Pharmaceuticals Inc., U	Manufacturing (CGMP) Deviations	Nationwide