Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Zonisamide Capsules USP Recalled by Glenmark Pharmaceuticals Inc., USA Due to cGMP deviations

Date: April 25, 2022
Company: Glenmark Pharmaceuticals Inc., USA
Status: Completed
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Glenmark Pharmaceuticals Inc., USA directly.

Affected Products

Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01

Quantity: 11,136 bottles

Why Was This Recalled?

cGMP deviations

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Glenmark Pharmaceuticals Inc., USA

Glenmark Pharmaceuticals Inc., USA has 139 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report