RecallRadar

FDA Drug recall D-1266-2015

Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter

On 2015-07-29 the FDA classified a Class II recall of Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter by Wockhardt Usa, citing CGMP Deviations: Firm did not adequately investigate customer complaints.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1266-2015
ClassificationClass II
Statusterminated
Initiated2015-04-22
Published2015-07-29
Last updated2026-09-13 11:51 UTC
CompanyWockhardt Usa
DistributionUS

Product

Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.

Reason

CGMP Deviations: Firm did not adequately investigate customer complaints.

Identifiers

code_infoLot #: LN11320, Expiry: 7/31/2015; Lot #: LN11341, Expiry: 8/31/2015.

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-1266-2015%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.