Data Foundry

Drug recalls 2018

Metformin Hydrochloride Extended Release Tablets — Class II drug recall D-0924-2018

Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2018-07-25, distributed in AZ. Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 C

Recall numberD-0924-2018
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSun Pharmaceutical Industries, Inc., Cranbury, NJ, United States
Recall initiated2018-07-03
Classified2018-07-13
Reported by FDA2018-07-25
Terminated2019-11-05
DistributedAZ
Quantity2,508 bottles
Reason classesforeign material
NDC62756-0142, 62756-0142-01, 62756-0142-02, 62756-0143, 62756-0143-01
Lot numbersJKT0042A
Expiration dates2021-01

Product

Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, NDC 62756-142-02

Reason for recall

Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0924-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.