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

Metformin Hydrochloride Extended-Release Tablets USP 500 mg recalled

Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets USP 500 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 # 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

Quantity recalled59,568 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-1384-2020
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 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07

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 # 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

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 1000 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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Other Metformin recalls

All 58

Reported	Class	Recall	Company	Reason	Where
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