FDA Drug recall D-1267-2015

Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter

FDA Drug
Class II
terminated
Published 2015-07-29

On 2015-07-29 the FDA classified a Class II recall of Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter 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-1267-2015
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

Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.

Reason

CGMP Deviations: Firm did not adequately investigate customer complaints.

Identifiers

code_info	Lot #: LM10826, Expiry: 5/31/2015; Lot #: LM10999, Expiry: 5/31/2015; Lot #: LM11016, Expiry: 6/30/2015; Lot #: LM11032… Lot #: LM10826, Expiry: 5/31/2015; Lot #: LM10999, Expiry: 5/31/2015; Lot #: LM11016, Expiry: 6/30/2015; Lot #: LM11032, Expiry: 6/30/2015; Lot #: LM11038, Expiry: 6/30/2015; Lot #: LM11087, Expiry: 6/30/2015; Lot #: LM11149, Expiry: 4/30/2015; Lot #: LM11156, Expiry: 4/30/2015; Lot #: LM11615, Expiry: 8/31/2015; Lot #: LN10195, Expiry: 12/31/2015; Lot #: LN10323, Expiry: 12/31/2015; Lot #: LN10500, Expiry: 1/31/2016; Lot #: LN10507, Expiry: 1/31/2016; Lot #: LN10514, Expiry: 2/29/2016; Lot #: LN10555, Expiry: 2/29/2016; Lot #: LN10556, Expiry: 2/29/2016; Lot #: LN10565, Expiry: 2/29/2016; Lot #: LN10784, Expiry: 3/31/2016; Lot #: LN10788, Expiry: 3/31/2016; Lot #: LN10831, Expiry: 3/31/2016; Lot #: LN10839, Expiry: 3/31/2016; Lot #: LN10846, Expiry: 3/31/2016; Lot #: LN10856, Expiry: 3/31/2016; Lot #: LN10884, Expiry: 3/31/2016; Lot #: LN10916, Expiry: 4/30/2016; Lot #: LN10931, Expiry: 4/30/2016; Lot #: LN10934, Expiry: 4/30/2016; Lot #: LN11067, Expiry: 5/31/2016; Lot #: LN11072, Ex

code_info

Lot #: LM10826, Expiry: 5/31/2015; Lot #: LM10999, Expiry: 5/31/2015; Lot #: LM11016, Expiry: 6/30/2015; Lot #: LM11032…

Lot #: LM10826, Expiry: 5/31/2015; Lot #: LM10999, Expiry: 5/31/2015; Lot #: LM11016, Expiry: 6/30/2015; Lot #: LM11032, Expiry: 6/30/2015; Lot #: LM11038, Expiry: 6/30/2015; Lot #: LM11087, Expiry: 6/30/2015; Lot #: LM11149, Expiry: 4/30/2015; Lot #: LM11156, Expiry: 4/30/2015; Lot #: LM11615, Expiry: 8/31/2015; Lot #: LN10195, Expiry: 12/31/2015; Lot #: LN10323, Expiry: 12/31/2015; Lot #: LN10500, Expiry: 1/31/2016; Lot #: LN10507, Expiry: 1/31/2016; Lot #: LN10514, Expiry: 2/29/2016; Lot #: LN10555, Expiry: 2/29/2016; Lot #: LN10556, Expiry: 2/29/2016; Lot #: LN10565, Expiry: 2/29/2016; Lot #: LN10784, Expiry: 3/31/2016; Lot #: LN10788, Expiry: 3/31/2016; Lot #: LN10831, Expiry: 3/31/2016; Lot #: LN10839, Expiry: 3/31/2016; Lot #: LN10846, Expiry: 3/31/2016; Lot #: LN10856, Expiry: 3/31/2016; Lot #: LN10884, Expiry: 3/31/2016; Lot #: LN10916, Expiry: 4/30/2016; Lot #: LN10931, Expiry: 4/30/2016; Lot #: LN10934, Expiry: 4/30/2016; Lot #: LN11067, Expiry: 5/31/2016; Lot #: LN11072, Ex

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-1267-2015%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.