FDA Drug recall D-1274-2015

Zonisamide Capsules, 25 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, 25 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-1274-2015
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, 25 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: 64679-0945-01.

Reason

CGMP Deviations: Firm did not adequately investigate customer complaints.

Identifiers

code_info	Lot #: LM10763, Expiry: 4/30/2015; Lot #: LM10764, Expiry: 4/30/2015; Lot #: LM10765, Expiry: 4/30/2015; Lot #: LM11142… Lot #: LM10763, Expiry: 4/30/2015; Lot #: LM10764, Expiry: 4/30/2015; Lot #: LM10765, Expiry: 4/30/2015; Lot #: LM11142, Expiry: 6/30/2015; Lot #: LM11143, Expiry: 6/30/2015; Lot #: LM11144, Expiry: 6/30/2015; Lot #: LM11255, Expiry: 7/31/2015; Lot #: LM11256, Expiry: 7/31/2015; Lot #: LM11265, Expiry: 7/31/2015; Lot #: LM11542, Expiry: 8/31/2015; Lot #: LM11543, Expiry: 8/31/2015; Lot #: LN10197, Expiry: 12/31/2015; Lot #: LN10198, Expiry: 12/31/2015; Lot #: LN10199, Expiry: 12/31/2015; Lot #: LN10200, Expiry: 12/31/2015; Lot #: LN10202, Expiry: 12/31/2015; Lot #: LN10203, Expiry: 12/31/2015; Lot #: LN10395, Expiry: 1/31/2016; Lot #: LN10396, Expiry: 1/31/2016; Lot #: LN10531, Expiry: 2/29/2016; Lot #: LN10532, Expiry: 2/29/2016; Lot #: LN10533, Expiry: 2/29/2016; Lot #: LN10534, Expiry: 2/29/2016; Lot #: LN10796, Expiry: 2/29/2016; Lot #: LN10942, Expiry: 4/30/2016.

code_info

Lot #: LM10763, Expiry: 4/30/2015; Lot #: LM10764, Expiry: 4/30/2015; Lot #: LM10765, Expiry: 4/30/2015; Lot #: LM11142…

Lot #: LM10763, Expiry: 4/30/2015; Lot #: LM10764, Expiry: 4/30/2015; Lot #: LM10765, Expiry: 4/30/2015; Lot #: LM11142, Expiry: 6/30/2015; Lot #: LM11143, Expiry: 6/30/2015; Lot #: LM11144, Expiry: 6/30/2015; Lot #: LM11255, Expiry: 7/31/2015; Lot #: LM11256, Expiry: 7/31/2015; Lot #: LM11265, Expiry: 7/31/2015; Lot #: LM11542, Expiry: 8/31/2015; Lot #: LM11543, Expiry: 8/31/2015; Lot #: LN10197, Expiry: 12/31/2015; Lot #: LN10198, Expiry: 12/31/2015; Lot #: LN10199, Expiry: 12/31/2015; Lot #: LN10200, Expiry: 12/31/2015; Lot #: LN10202, Expiry: 12/31/2015; Lot #: LN10203, Expiry: 12/31/2015; Lot #: LN10395, Expiry: 1/31/2016; Lot #: LN10396, Expiry: 1/31/2016; Lot #: LN10531, Expiry: 2/29/2016; Lot #: LN10532, Expiry: 2/29/2016; Lot #: LN10533, Expiry: 2/29/2016; Lot #: LN10534, Expiry: 2/29/2016; Lot #: LN10796, Expiry: 2/29/2016; Lot #: LN10942, Expiry: 4/30/2016.

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-1274-2015%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.