Reported Jul 22, 2020 · Terminated

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 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, 90 count bottles, Rx only
Manufactured forLupin Pharmaceuticals, Inc
Manufactured byLupin Limited, Goa INDIA NDC 68180-339-09

Lot codes and dates: Batch #
94 of 94 codes
G807093
Jul-20
G807147
Jul-20
G807208
Jul-20
G807479
Jul-20
G807480
Jul-20
G807830
Jul-20
G807092
Jul-20
G809471
Jul-20
G808155
Aug-20
G808074
Aug-20
G808115
Aug-20
G900231
Nov-20
G900232
Nov-20
G903277
Mar-21
G903278
Mar-21
G903279
Mar-21
G903280
Mar-21
G903281
Mar-21
G903818
Apr-21
G904048
Apr-21
G904164
Apr-21
G906548
Jul-21
G907239
Aug-21
G907255
Aug-21
G907256
Aug-21
G907263
Aug-21
G001802
Jan-22
G001804
Jan-22
G001803
Jan-22
G001805
Jan-22
Amount recalled: 95,886 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.

Free recall alerts

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.

84 in total.