FDA Drug recall D-1343-2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LL…
- 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, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LL… 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-1343-2020 |
| 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, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Identifiers
| code_info | HA07419A 1/31/2021 HB00119A 1/31/2021 HB00219A 1/31/2021 HB00319A 1/31/2021; HB00419A 2/28/2021 HB00519A 2/28/2021…HA07419A 1/31/2021 HB00119A 1/31/2021 HB00219A 1/31/2021 HB00319A 1/31/2021; HB00419A 2/28/2021 HB00519A 2/28/2021 HB00619A 2/28/2021 HB00719A 2/28/2021 HB00819A 2/28/2021 HB00919A 2/28/2021 HB01019A 2/28/2021 HB05119A 2/28/2021 HB05219A 2/28/2021 HB05319A 2/28/2021 HB05419A 2/28/2021 HB05519A 2/28/2021 HB09519A 2/28/2021 HB09619A 2/28/2021 HB09719A 2/28/2021 HB09819A 2/28/2021 HB09919A 2/28/2021; HC08219A 3/31/2021 HC08319A 3/31/2021 HC08419A 3/31/2021 HC08519A 3/31/2021 HC09019A 3/31/2021 HC09119A 3/31/2021 HC09219A 3/31/2021 HC09319A 3/31/2021 HC09419A 3/31/2021; HD03419B 4/30/2021 HD03519B 4/30/2021 HD03619B 4/30/2021 HD03719B 4/30/2021 HD03819B 4/30/2021 HD03919B 4/30/2021 HD04019B 4/30/2021 HD04119B 4/30/2021 HD04219A 4/30/2021 HD05819A 4/30/2021 HD05919A 4/30/2021 HD06019A 4/30/2021 HD06119A 4/30/2021 HD06219A 4/30/2021 HD06319A 4/30/2021 HD06419A 4/30/2021 HD09019A 4/30/2021 HD09119A 4/30/2021 HD09219A 4/30/2021 HE01219B 4/30/2 |
|---|
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-1343-2020%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.