FDA Drug recall D-1254-2015

Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only

FDA Drug
Class II
terminated
Published 2015-07-29

On 2015-07-29 the FDA classified a Class II recall of Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only by Wockhardt Usa, citing CGMP Deviations: Firm did not adequately investigate customer complaints.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1254-2015
Classification	Class II
Status	terminated
Initiated	2015-04-22
Published	2015-07-29
Last updated	2026-09-13 11:51 UTC
Company	Wockhardt Usa
Distribution	US

Product

Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01.

Reason

CGMP Deviations: Firm did not adequately investigate customer complaints.

Identifiers

code_info	Lot #: LM10776, Expiry: 5/31/2015; Lot #: LM10781, Expiry: 5/31/2015; Lot #: LM10783, Expiry: 5/31/2015; Lot #: LM10923… Lot #: LM10776, Expiry: 5/31/2015; Lot #: LM10781, Expiry: 5/31/2015; Lot #: LM10783, Expiry: 5/31/2015; Lot #: LM10923, Expiry: 4/30/2015; Lot #: LM10924, Expiry: 4/30/2015; Lot #: LM10925, Expiry: 4/30/2015; Lot #: LM10926, Expiry: 5/31/2015; Lot #: LM10927, Expiry: 5/31/2015; Lot #: LM10937, Expiry: 6/30/2015; Lot #: LM11138, Expiry: 6/30/2015; Lot #: LM11139, Expiry: 6/30/2015; Lot #: LM11141, Expiry: 6/30/2015; Lot #: LM11180, Expiry: 6/30/2015; Lot #: LM11181, Expiry: 6/30/2015; Lot #: LM11319, Expiry: 7/31/2015; Lot #: LM11320, Expiry: 7/31/2015; Lot #: LM11356, Expiry: 7/31/2015; Lot #: LM11357, Expiry: 7/31/2015; Lot #: LM11363, Expiry: 7/31/2015; Lot #: LM11407, Expiry: 7/31/2015; Lot #: LM11558, Expiry: 8/31/2015; Lot #: LM11730, Expiry: 9/30/2015; Lot #: LM11737, Expiry: 9/30/2015; Lot #: LM11744, Expiry: 9/30/2015, Lot #: LM11754, Expiry: 9/30/2015; Lot #: LM11860, Expiry: 10/31/2015; Lot #: LM11861, Expiry: 10/31/2015; Lot #: LM11904, Expiry: 10/31/2015; Lot #: LM11905, E

code_info

Lot #: LM10776, Expiry: 5/31/2015; Lot #: LM10781, Expiry: 5/31/2015; Lot #: LM10783, Expiry: 5/31/2015; Lot #: LM10923…

Lot #: LM10776, Expiry: 5/31/2015; Lot #: LM10781, Expiry: 5/31/2015; Lot #: LM10783, Expiry: 5/31/2015; Lot #: LM10923, Expiry: 4/30/2015; Lot #: LM10924, Expiry: 4/30/2015; Lot #: LM10925, Expiry: 4/30/2015; Lot #: LM10926, Expiry: 5/31/2015; Lot #: LM10927, Expiry: 5/31/2015; Lot #: LM10937, Expiry: 6/30/2015; Lot #: LM11138, Expiry: 6/30/2015; Lot #: LM11139, Expiry: 6/30/2015; Lot #: LM11141, Expiry: 6/30/2015; Lot #: LM11180, Expiry: 6/30/2015; Lot #: LM11181, Expiry: 6/30/2015; Lot #: LM11319, Expiry: 7/31/2015; Lot #: LM11320, Expiry: 7/31/2015; Lot #: LM11356, Expiry: 7/31/2015; Lot #: LM11357, Expiry: 7/31/2015; Lot #: LM11363, Expiry: 7/31/2015; Lot #: LM11407, Expiry: 7/31/2015; Lot #: LM11558, Expiry: 8/31/2015; Lot #: LM11730, Expiry: 9/30/2015; Lot #: LM11737, Expiry: 9/30/2015; Lot #: LM11744, Expiry: 9/30/2015, Lot #: LM11754, Expiry: 9/30/2015; Lot #: LM11860, Expiry: 10/31/2015; Lot #: LM11861, Expiry: 10/31/2015; Lot #: LM11904, Expiry: 10/31/2015; Lot #: LM11905, E

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-1254-2015%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.