METFORMIN HYDROCHLORIDE

Generic: METFORMIN HYDROCHLORIDE

Oceanside PharmaceuticalsManufacturer
ORALRoute
METFORMIN HYDROCHLORIDEActive Substance
2005-06-03Original Approval

METFORMIN HYDROCHLORIDE is FDA application NDA021748, sponsored by SANTARUS INC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class III2021-03-25
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceuti

Failed Moisture Limits: Out of specification for water content

Class II2025-02-25
METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60

Presence of Foreign Tablets/Capsules.

Class II2020-06-05
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactur

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

Class II2020-05-29
amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, Rx only, 100 Tablets bottles, Manufactured by: Amn

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

Class II2020-10-02
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake lev

Class III2018-02-02
Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc.

Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg

Class II2020-08-19
Metformin Hydrochloride Extended-Release Tablets USP, 750 mg 100 Tablets Rx Only Manufactured by: Beximco Pharmaceutical

CGMP Deviations

Class II2021-06-01
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare L

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily

Class II2020-10-06
metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake lev

Class II2021-12-27
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01

CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily

Top Reported Reactions

1
DIARRHOEA
22,997 reports
2
NAUSEA
22,974 reports
3
DRUG INEFFECTIVE
18,986 reports
4
BLOOD GLUCOSE INCREASED
18,666 reports
5
FATIGUE
17,940 reports
6
ACUTE KIDNEY INJURY
17,318 reports
7
LACTIC ACIDOSIS
17,277 reports
8
VOMITING
15,576 reports
9
OFF LABEL USE
14,159 reports
10
DYSPNOEA
14,060 reports