FDAClass IIMay 4, 2022

Zonisamide Capsules recall: CGMP Deviations

Zonisamide Capsules, USP, 50 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 68462-129-01

Why was Zonisamide Capsules recalled?

cGMP deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 29200064, Exp 5/31/2023

Product
Zonisamide Capsules, USP, 50 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 68462-129-01
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Quantity
12,003 bottles
Distribution
USA nationwide
Recall date
May 4, 2022
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls