Metformin Hydrochloride Tablet, Extended Release
FDA Recall NDC 62756-142
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Metformin Hydrochloride (NDC 62756-142). A significant event, classified as Class II, was initiated on May 04, 2021 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Presence of foreign substance: identified as activated carbon."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of foreign substance: identified as activated carbon.
May 04, 2021
May 19, 2021
50868 bottles
Recall Profile & Regulatory Data
Event ID
87869
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Jun 27, 2023
Product Description
Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bottles, 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.
Batch or Lot Expiration Information
Lot# Lots #: JKX2749A, JKX2803A, JKX2804A, JKX2805A, JKX806A, JKX2945A,JKX2946A, JXK2947A, JKX2948A, JKX2952A, JKX2953A, JKX2954A & JKX3224A, Exp 6/2032; JKX3211A, JKX3212A, Exp 7/2023.
Affected Packages Involved in this Recall
62756-142-01Product
62756-142-02Product
62756-143-01Product
Class III Terminated
Failed Moisture Limits: Out of specification for water content
Mar 25, 2021
Apr 14, 2021
2520 bottles
Recall Profile & Regulatory Data
Event ID
87617
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Apr 14, 2022
Product Description
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 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.
Batch or Lot Expiration Information
Lot# JKU4639A, Exp 10/2022
Affected Packages Involved in this Recall
62756-142-01Product
62756-142-02Product
62756-143-01Product
Class II Terminated
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.
Jul 03, 2018
Jul 25, 2018
2508 bottles
Recall Profile & Regulatory Data
Event ID
80440
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
AZ
Termination Date
Nov 05, 2019
Product Description
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
Batch or Lot Expiration Information
Lot# : JKT0042A, Exp 1/2021
Affected Packages Involved in this Recall
62756-142-01Product
62756-142-02Product
62756-143-01Product
January 2014 Class II Recall: Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Recall Number
Class II Terminated
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Jan 28, 2014
Mar 05, 2014
2528 bottles
Recall Profile & Regulatory Data
Event ID
67433
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Caraco Pharmaceutical Laboratories, Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 29, 2014
Product Description
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
Batch or Lot Expiration Information
Batch# Batch JKM2433A, Mfg Date 04/2013; Exp 03/2016
Affected Packages Involved in this Recall
62756-142-01Product
62756-142-02Product
62756-143-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
