Metformin Hydrochloride Tablet, Extended Release
FDA Recall NDC 68180-337
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Metformin Hydrochloride (NDC 68180-337). A significant event, classified as Class II, was initiated on Jul 07, 2020 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level"
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
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Jul 07, 2020
Jul 22, 2020
273,060 bottles
Recall Profile & Regulatory Data
Event ID
85998
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States.
Termination Date
Dec 23, 2021
Product Description
Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07
Batch or Lot Expiration Information
Batch# G807619 Jul-20 G807620 Jul-20 G807733 Jul-20 G807734 Jul-20 G807735 Jul-20 G807445 Jul-20 G807617 Jul-20 G807618 Jul-20 G808042 Jul-20 G808043 Jul-20 G807349 Jul-20 G807350 Jul-20 G807444 Jul-20 G807507 Jul-20 G807508 Jul-20 G807314 Jul-20 G807316 Jul-20 G807325 Jul-20 G807348 Jul-20 G807616 Jul-20 G807312 Jul-20 G807313 Jul-20 G807315 Jul-20 G808374 Aug-20 G808427 Aug-20 G808373 Aug-20 G808426 Aug-20 G900057 Oct-20 G900058 Oct-20 G900059 Oct-20 G900060 Oct-20 G900061 Oct-20 G900062 Oct-20 G900106 Oct-20 G900140 Oct-20 G900141 Oct-20 G900152 Oct-20 G809596 Oct-20 G809598 Oct-20 G810182 Oct-20 G810183 Oct-20 G810184 Oct-20 G810185 Oct-20 G810186 Oct-20 G810187 Oct-20 G810188 Oct-20 G810189 Oct-20 G809554 Oct-20 G809556 Oct-20 G809557 Oct-20 G809558 Oct-20 G809559 Oct-20 G809548 Oct-20 G809549 Oct-20 G809550 Oct-20 G809551 Oct-20 G809552 Oct-20 G809553 Oct-20 G809555 Oct-20 G901004 Dec-20 G901005 Dec-20 G901053 Dec-20 G901002 Dec-20 G901003 Dec-20 G903182 Mar-21 G903183 Mar-21 G903236 Mar-21 G903237 Mar-21 G903238 Mar-21 G903155 Mar-21 G903156 Mar-21 G903157 Mar-21 G903158 Mar-21 G903159 Mar-21 G903178 Mar-21 G903179 Mar-21 G903180 Mar-21 G903181 Mar-21 G903239 Mar-21 G001837 Jan-22 G001860 Jan-22 G001861 Jan-22 G001905 Jan-22 G001933 Jan-22 G001934 Jan-22 G001763 Jan-22 G001764 Jan-22 G001765 Jan-22 G001766 Jan-22 G001767 Jan-22 G001795 Jan-22 G001836 Jan-22
Affected Packages Involved in this Recall
68180-336-07Product
68180-336-02Product
68180-336-01Product
68180-337-07Product
68180-337-01Product
68180-337-02Product
Class II Terminated
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Jul 07, 2020
Jul 22, 2020
59,568 bottles
Recall Profile & Regulatory Data
Event ID
85998
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States.
Termination Date
Dec 23, 2021
Product Description
Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07
Batch or Lot Expiration Information
Batch# G808293 Aug-20 G808284 Aug-20 G808285 Aug-20 G808343 Aug-20 G901201 Dec-20 G901202 Dec-20 G906915 Jul-21 G906913 Jul-21 G906914 Jul-21 G002135 Jan-22 G002849 Feb-22
Affected Packages Involved in this Recall
68180-336-07Product
68180-336-02Product
68180-336-01Product
68180-337-07Product
68180-337-01Product
68180-337-02Product
Class II Terminated
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Jun 11, 2020
Jul 01, 2020
6,540 bottles
Recall Profile & Regulatory Data
Event ID
85840
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout the United States.
Termination Date
Dec 23, 2021
Product Description
Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07)
Batch or Lot Expiration Information
Batch# G901203, exp. date 12/2020
Affected Packages Involved in this Recall
68180-336-07Product
68180-336-02Product
68180-336-01Product
68180-337-07Product
68180-337-01Product
68180-337-02Product
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.
