Reported Jul 22, 2020 · Terminated

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin…

Lupin Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only
Manufactured forLupin Pharmaceuticals, Inc
Manufactured byLupin Limited, Goa INDIA NDC 68180-337-07

Lot codes and dates: Batch #
184 of 184 codes
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
Amount recalled: 273,060 bottles

The agency filed one notice per product. You are reading one of them; the other 3 are below.

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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84 in total.