RecallRadar

FDA Drug recall D-1089-2014

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc

On 2014-03-05 the FDA classified a Class II recall of Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc by Caraco Pharmaceutical Laboratories, citing presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1089-2014
ClassificationClass II
Statusterminated
Initiated2014-01-28
Published2014-03-05
Last updated2026-09-13 11:51 UTC
CompanyCaraco Pharmaceutical Laboratories
DistributionUS

Product

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02

Reason

Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER

Identifiers

ndc62756-142-01
ndc62756-142-02
ndc62756-143-01
code_infoBatch JKM2433A, Mfg Date 04/2013; Exp 03/2016

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-1089-2014%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.