FDA Drug recall D-1350-2020
amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53…
- 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, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53… 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-1350-2020 |
| 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, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-BULK
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Identifiers
| code_info | HA01320A 1/31/2021 HA01420A 1/31/2021 HA06820A 1/31/2021 HB03620A 1/31/2021 HB03720A 1/31/2021 HB03820A 1/31/2021…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 HB08220A 2/28/2021 HF05519A 6/30/2020 HF05619A 6/30/2020 HF05719A 6/30/2020 HF05819A 6/30/2020 HF05919A 6/30/2020 HF06019A 6/30/2020 HF06119A 6/30/2020 HF06219A 6/30/2020 HF06319A 6/30/2020 HF07719A 6/30/2020 HF07819A 6/30/2020 HF07919A 6/30/2020 HF08019A 6/30/2020 HF08119A 6/30/2020 HF08219A 6/30/2020 HF08319A 6/30/2020 HF08419A 6/30/2020 HF08519A 6/30/2020 HF08619A 6/30/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class III · 2026-06-17 · Amneal Pharmaceuticals - traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt
FDA Drug · Class II · 2026-04-08 · Amneal Pharmaceuticals - Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufact…
FDA Drug · Class I · 2026-04-08 · Amneal Pharmaceuticals
All Amneal Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1350-2020%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.