FDA Drug recall D-1354-2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 088…
- FDA Drug
- Class II
- ongoing
- Published 2020-07-01
On 2020-07-01 the FDA classified a Class II recall of amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 088… by Amneal Pharmaceuticals, citing CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1354-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-05-29 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amneal Pharmaceuticals |
| Distribution | US |
Product
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Identifiers
| code_info | HA01520A 1/31/2021 HA01620A 1/31/2021 HG01719A 7/31/2020 HG01819A 7/31/2020 HH09319A 8/31/2020 HH09419A 9/30/2020 HK07619A 10/31/2020 HK07719A 10/31/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1354-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.