FDA Drug recall D-1250-2015

Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and…

FDA Drug
Class II
terminated
Published 2015-07-29

On 2015-07-29 the FDA classified a Class II recall of Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and… 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-1250-2015
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, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Reason

CGMP Deviations: Firm did not adequately investigate customer complaints.

Identifiers

code_info	A) Lot #: LM10806, Expiry: 5/31/2015; Lot #: LM11099, Expiry: 6/30/2015; Lot #: LM11297, Expiry: 7/31/2015; Lot #: LM11… A) Lot #: LM10806, Expiry: 5/31/2015; Lot #: LM11099, Expiry: 6/30/2015; Lot #: LM11297, Expiry: 7/31/2015; Lot #: LM11933, Expiry: 10/31/2015; Lot #: LN10180, Expiry: 12/31/2015; Lot #: LN10547, Expiry: 2/29/2016. B) Lot #: LM10784, Expiry: 5/31/2015; Lot #: LM10791, Expiry: 5/31/2015; Lot #: LM10812, Expiry: 5/31/2015; Lot #: LM11112, Expiry: 6/30/2015; Lot #: LM11298, Expiry: 7/31/2015; Lot #: LM11299, Expiry: 7/31/2015; Lot #: LM11625, Expiry: 8/31/2015; Lot #: LN10182, Expiry: 12/31/2015; Lot #: LN10548, Expiry: 2/29/2016; Lot #: LN11115, Expiry: 5/31/2016; Lot #: LN11367, Expiry: 8/31/2016; Lot #: LN11369, Expiry: 8/31/2016. C) Lot #: LM10813, Expiry: 5/31/2015; Lot #: LM11085, Expiry: 6/30/2015; Lot #: LM11088, Expiry: 6/30/2015; Lot #: LM11296, Expiry: 7/31/2015; Lot #: LM11932, Expiry: 10/31/2015; Lot #: LN10181, Expiry: 12/31/2015; Lot #: LN10549, Expiry: 2/29/2016; Lot #: LN11114, Expiry: 5/31/2016; Lot #: LN11359, Expiry: 8/31/2016.

code_info

A) Lot #: LM10806, Expiry: 5/31/2015; Lot #: LM11099, Expiry: 6/30/2015; Lot #: LM11297, Expiry: 7/31/2015; Lot #: LM11…

A) Lot #: LM10806, Expiry: 5/31/2015; Lot #: LM11099, Expiry: 6/30/2015; Lot #: LM11297, Expiry: 7/31/2015; Lot #: LM11933, Expiry: 10/31/2015; Lot #: LN10180, Expiry: 12/31/2015; Lot #: LN10547, Expiry: 2/29/2016. B) Lot #: LM10784, Expiry: 5/31/2015; Lot #: LM10791, Expiry: 5/31/2015; Lot #: LM10812, Expiry: 5/31/2015; Lot #: LM11112, Expiry: 6/30/2015; Lot #: LM11298, Expiry: 7/31/2015; Lot #: LM11299, Expiry: 7/31/2015; Lot #: LM11625, Expiry: 8/31/2015; Lot #: LN10182, Expiry: 12/31/2015; Lot #: LN10548, Expiry: 2/29/2016; Lot #: LN11115, Expiry: 5/31/2016; Lot #: LN11367, Expiry: 8/31/2016; Lot #: LN11369, Expiry: 8/31/2016. C) Lot #: LM10813, Expiry: 5/31/2015; Lot #: LM11085, Expiry: 6/30/2015; Lot #: LM11088, Expiry: 6/30/2015; Lot #: LM11296, Expiry: 7/31/2015; Lot #: LM11932, Expiry: 10/31/2015; Lot #: LN10181, Expiry: 12/31/2015; Lot #: LN10549, Expiry: 2/29/2016; Lot #: LN11114, Expiry: 5/31/2016; Lot #: LN11359, Expiry: 8/31/2016.

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-1250-2015%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.