RecallRadar

FDA Drug recall D-1349-2020

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals…

On 2020-07-01 the FDA classified a Class II recall of amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals… by Amneal Pharmaceuticals, citing CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1349-2020
ClassificationClass II
Statusongoing
Initiated2020-05-29
Published2020-07-01
Last updated2026-09-13 11:52 UTC
CompanyAmneal Pharmaceuticals
DistributionUS

Product

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-179-10

Reason

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Identifiers

ndc65162-178-89
ndc65162-178-03
ndc65162-178-09
ndc65162-178-10
ndc65162-178-50
ndc65162-178-11
ndc65162-179-03
ndc65162-179-09
ndc65162-179-10
ndc65162-179-50
code_info
AM181337A 10/31/2020 AM181338A 10/31/2020 AM181339A 11/30/2020 AM181340A 11/30/2020 AM181341A 11/30/2020 AM181342A…AM181337A 10/31/2020 AM181338A 10/31/2020 AM181339A 11/30/2020 AM181340A 11/30/2020 AM181341A 11/30/2020 AM181342A 11/30/2020 AM181343A 11/30/2020 AM181344A 11/30/2020 AM181356A 11/30/2020 AM181357A 11/30/2020 AM181358A 11/30/2020 AM181359A 11/30/2020 AM181360A 11/30/2020 AM181361A 11/30/2020 AM181362A 11/30/2020 AM181363A 11/30/2020 AM181415A 11/30/2020 AM190040B 12/31/2020 AM190041A 12/31/2020 AM190042A 12/31/2020 AM190043A 12/31/2020 AM190044A 12/31/2020 AM190045A 12/31/2020 AM190046A 12/31/2020 AM190473B 4/30/2021 AM190474A 4/30/2021 AM190475A 4/30/2021 AM190476A 4/30/2021 AM190477A 4/30/2021 AM190478A 4/30/2021 AM190479A 4/30/2021 AM190480A 4/30/2021 AM190481A 4/30/2021 AM190482A 4/30/2021 AM190834A 7/31/2021 AM190835A 7/31/2021 AM190836A 7/31/2021 AM190837A 7/31/2021 AM190838A 7/31/2021 AM191004A 8/31/2021 AM191005A 8/31/2021 AM191006A 8/31/2021 AM191007A 8/31/2021 AM191008A 9/30/2021 AM191271A 10/31/2021 AM191272A 10/31/2021 AM191273

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-1349-2020%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.