Reported Jul 1, 2020 · Ongoing

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC…

Amneal Pharmaceuticals of New York, LLC

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: Amneal Pharmaceuticals of New York, LLC · 50 Horseblock Rd · Brookhaven, NY · 11719-9509

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk
Distributed byAmneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK

Lot codes and dates: 242 of 242 codes
HA01320A
1/31/2021
HA01420A
1/31/2021
HA06820A
1/31/2021
HB03620A
1/31/2021
HB03720A
1/31/2021
HB03820A
1/31/2021
HB03920A
1/31/2021
HB04020A
1/31/2021
HB04120A
1/31/2021
HB04220A
1/31/2021
HB04320A
2/28/2021
HB04420A
1/31/2021
HB04520A
2/28/2021
HB05020A
2/28/2021
HB05120A
2/28/2021
HB05220A
2/28/2021
HB05320A
2/28/2021
HB05420A
2/28/2021
HB05520A
2/28/2021
HB05620A
2/28/2021
HB07020A
2/28/2021
HB07120A
2/28/2021
HB07220A
2/28/2021
HB07320A
2/28/2021
HB07520A
2/28/2021
HB07620A
2/28/2021
HB07720A
2/28/2021
HB07820A
2/28/2021
HB07920A
2/28/2021
HB08020A
2/28/2021
Amount recalled: N/A

The agency filed one notice per product. You are reading one of them; the other 11 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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13 in total.