FDA Drug Recalls

58 recalls · Class II, newest first

Nov 1, 2020 Class II · Moderate risk

Metformin HCl Extended Release Tablets USP 500 mg

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Terminated Nitrosamine impurity Preferred Pharmaceuticals, Inc. D-0077-2021

Oct 23, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-Release Tablets

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

Ongoing Nitrosamine impurity Nostrum Laboratories Inc NDC 29033-055-01 D-0068-2021

Oct 23, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-Release Tablets

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

Ongoing Nitrosamine impurity Nostrum Laboratories Inc NDC 29033-056-01 D-0067-2021

Oct 12, 2020 Class II · Moderate risk

Metformin HCL E/R 500 mg

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

Terminated Nitrosamine impurity Direct Rx NDC 72189-064-90 D-0058-2021

Oct 11, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended Release 750 mg

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

Terminated Nitrosamine impurity RemedyRepack Inc. NDC 70518-2480-00 D-0050-2021

Oct 8, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-Release Tablets

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

Ongoing Nitrosamine impurity Denton Pharma, Inc. NDC 70934-309-30 D-0057-2021

Oct 8, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-Release Tablets USP 750 mg

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

Ongoing Nitrosamine impurity Denton Pharma, Inc. NDC 70934-334-30 D-0056-2021

Oct 6, 2020 Class II · Moderate risk

metformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City

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

Terminated Nitrosamine impurity PD-Rx Pharmaceuticals, Inc. D-0060-2021

Oct 6, 2020 Class II · Moderate risk

metformin HCL ER 500 mg

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

Terminated Nitrosamine impurity PD-Rx Pharmaceuticals, Inc. D-0059-2021

Oct 2, 2020 Class II · Moderate risk

Time-Cap Labs

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

Terminated Nitrosamine impurity Marksans Pharma Limited NDC 49483-624-01 D-0062-2021

Oct 2, 2020 Class II · Moderate risk

Time-Cap Labs

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

Terminated Nitrosamine impurity Marksans Pharma Limited NDC 49483-623-09 D-0061-2021

Sep 23, 2020 Class II · Moderate risk

RIOMET ER (metformin hydrochloride for extended-release oral suspension)

CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.

Terminated Nitrosamine impurity Sun Pharmaceutical Industries INC NDC 10631-019-17 D-0002-2021

Jul 7, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg

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

Terminated Nitrosamine impurity Lupin Pharmaceuticals Inc. NDC 68180-337-07 D-1385-2020

Jul 7, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-Release Tablets USP 500 mg

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

Terminated Nitrosamine impurity Lupin Pharmaceuticals Inc. NDC 68180-336-07 D-1384-2020

Jul 7, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg

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

Terminated Nitrosamine impurity Lupin Pharmaceuticals Inc. NDC 68180-339-09 D-1383-2020

Jul 7, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-release Tablets USP 500 mg

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

Terminated Nitrosamine impurity Lupin Pharmaceuticals Inc. NDC 68180-338-01 D-1382-2020

Jul 3, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-Release Tablets USP

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

Ongoing Nitrosamine impurity Granules Pharmaceuticals Inc NDC 70010-492-01 D-1386-2020

Jun 17, 2020 Class II · Moderate risk

Metformin HCl Extended Release Tablets

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Terminated Nitrosamine impurity Preferred Pharmaceuticals, Inc. D-1364-2020

Jun 12, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-Release Tablets

CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.

Terminated Nitrosamine impurity The Harvard Drug Group NDC 00904-5794-61 D-1360-2020

Jun 11, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-release Tablets USP

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

Terminated Nitrosamine impurity Lupin Pharmaceuticals Inc. NDC 68180-336-07 D-1334-2020

Jun 5, 2020 Class II · Moderate risk

Time-Cap Labs

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

Terminated Nitrosamine impurity Marksans Pharma Limited NDC 49483-623-01 D-1356-2020

Jun 5, 2020 Class II · Moderate risk

metFORMIN HCL ER 500 mg

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

Terminated Nitrosamine impurity PD-Rx Pharmaceuticals, Inc. NDC 72789-009-30 D-1333-2020

Jun 5, 2020 Class II · Moderate risk

metFORMIN HCL ER USP 500 mg

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

Terminated Nitrosamine impurity PD-Rx Pharmaceuticals, Inc. D-1307-2020

Jun 4, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-Release Tablets

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

Terminated Nitrosamine impurity AVKARE Inc. NDC 50268-531-15 D-1305-2020

Jun 4, 2020 Class II · Moderate risk

Metformin Hydrochloride Extended-Release Tablets

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

Terminated Nitrosamine impurity AVKARE Inc. NDC 42291-611-90 D-1304-2020

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061