CLASS II Drug recall · Reported 1 Jun 2022 · FDA Enforcement Report

Zonisamide Capsules USP, 100 mg recalled by Direct Rx

Direct Rx is recalling Zonisamide Capsules USP, 100 mg, distributed nationwide in the US. The recall was initiated on 13 May 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 23JY2124 Exp. 6/30/23

Quantity recalled16 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-0888-2022
FDA event ID: 90215
Recalling firm: Direct Rx, Dawsonville, GA
Classification: Class II
Status: Terminated
Recall initiated: 13 May 2022
FDA classified: 20 May 2022
Reported: 1 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations

Timeline

13 May 2022	Recall initiated by company
20 May 2022	Classified by FDA	+7 days
1 Jun 2022	Published in enforcement report	+12 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: Gaps in the quality system in the Quality Control microbiology laboratory.

Product as listed by the FDA

Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90

Where it was distributed

Nationwide to the U.S. market

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.

Which lots are affected?

Lot: 23JY2124 Exp. 6/30/23

Where was it sold?

Nationwide to the U.S. market

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

More recalls from Direct Rx

All 37

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1 Jul 2026Drug	CLASS II	Duloxetine D/R, a) 30 mg recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
13 Aug 2025Drug	CLASS II	Duloxetine D/R, 30 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
13 Aug 2025Drug	CLASS II	Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
23 Apr 2025Drug	CLASS II	Ciprofloxacin Ophth Solution recalled by Direct Rx	Direct Rx	Packaging Defects	5 states
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Other Zonisamide recalls

All 11

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