FDA Drug recall D-331-2013

Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Lt…

FDA Drug
Class III
terminated
Published 2013-05-22

On 2013-05-22 the FDA classified a Class III recall of Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Lt… by Glenmark Generics Usa, citing chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-331-2013
Classification	Class III
Status	terminated
Initiated	2013-04-05
Published	2013-05-22
Last updated	2026-09-13 11:51 UTC
Company	Glenmark Generics Usa
Distribution	US

Product

Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430

Reason

Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.

Identifiers

ndc	68462-108-60
ndc	68462-108-05
ndc	68462-108-10
ndc	68462-153-60
ndc	68462-153-05
ndc	68462-153-10
ndc	68462-109-60
ndc	68462-109-05
ndc	68462-109-10
ndc	68462-110-60
ndc	68462-110-05
ndc	68462-110-10
code_info	Lot# 02123782, Exp 11/14

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-331-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.