FDA Drug recall D-1393-2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC…
- 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, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC… 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-1393-2020 |
| 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, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Identifiers
| code_info | HB10019A 03-2021 HB10119A 03-2021 HB10219A 03-2021 HB10319A 03-2021 HD02119A 04-2021 HD03319A 04-2021 HF09118A 06…HB10019A 03-2021 HB10119A 03-2021 HB10219A 03-2021 HB10319A 03-2021 HD02119A 04-2021 HD03319A 04-2021 HF09118A 06-2020 HF11618A 06-2020 HF15218A 07-2020 HF15318A 07-2020 HJ01418A 09-2020 HJ01518A 09-2020 HJ01618A 09-2020 HJ01718A 09-2020 HJ04718A 09-2020 HK03218A 10-2020 HK03318A 10-2020 HK03418A 10-2020 HK03518A 10-2020 HK03618A 10-2020 HK13718A 11-2020 HK13818A 11-2020 HK13918A 11-2020 HK14018A 11-2020 HK14118A 11-2020 HK14218A 11-2020 HK14318A 11-2020 HK14418A 11-2020 HK14518A 11-2020 HM00118A 11-2020 |
|---|
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-1393-2020%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.