CLASS II Drug recall · Reported 22 Jul 2020 · FDA Enforcement Report

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg recalled

Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, distributed nationwide in the US. The recall was initiated on 7 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch # 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

Quantity recalled273,060 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1385-2020
FDA event ID: 85998
Recalling firm: Lupin Pharmaceuticals, Baltimore, MD
Classification: Class II
Status: Terminated
Recall initiated: 7 Jul 2020
FDA classified: 14 Jul 2020
Reported: 22 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Nitrosamine Impurity
Drug class: Diabetes Medication

Timeline

7 Jul 2020	Recall initiated by company
14 Jul 2020	Classified by FDA	+7 days
22 Jul 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.

Product as listed by the FDA

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

Where it was distributed

Product was distributed throughout the United States.

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Which lots are affected?

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

Where was it sold?

Product was distributed throughout the United States.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 30 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 85998

This product is part of a recall event; the main page for the event is Metformin Hydrochloride Extended-release Tablets USP 500 mg recalled.

Reported	Class	Recall	Company	Reason	Where
22 Jul 2020	CLASS II	Metformin Hydrochloride Extended-release Tablets USP 500 mg recalled	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
22 Jul 2020	CLASS II	Metformin Hydrochloride Extended-Release Tablets USP 500 mg recalled	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide
22 Jul 2020	CLASS II	Metformin Hydrochloride Extended-Release Tablets USP 1000 mg recalled	Lupin Pharmaceuticals	Nitrosamine Impurity	Nationwide

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16 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets 1000mg recalled	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
2 Apr 2025Drug	CLASS II	Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride	A-S Medication Solutions	Packaging Defects	Nationwide
15 Jan 2025Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg recalledMetformin Er 500 Mg	Granules Pharmaceuticals	Other	OH
15 Mar 2023Drug	CLASS II	Metformin hydrochloride Extended-Release Tablets, 1000 mg recalled	Teva Pharmaceuticals USA	Nitrosamine Impurity	CA
2 Feb 2022Drug	CLASS II	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg HDPE recalledMetformin Hydrochloride	Viona Pharmaceuticals	Nitrosamine Impurity	NJ