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Diabetes drug recalls

Every Class I, II, and III FDA recall affecting diabetes medications. Drugs in this category include Metformin, Insulin Glargine, Sitagliptin.

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March 10, 20211 recall

November 11, 20205 recalls

RecallClassStatus
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake… · Direct Rx · 88 bottlesClass IITerminatedTime-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg, a) 90 count (NDC 49483-623-09) b) 100 count (49483-623-01) c) 500 count (NDC 49483-623-50) and d) 1000 count (NDC 49483-623-10) bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-623-50CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake… · Marksans Pharma Limited · a) 64,590 b) 23,834 c) 109,125 d) 27839 bottlesClass IITerminatedTime-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg, 100 count bottles, Rx Only Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate. Verna Goa-403 722 India NDC 49483-624-01CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake… · Marksans Pharma Limited · 368,976 bottlesClass IITerminatedmetformin HCL ER 500 mg, a) 30 tablets NDC: 72789-009-30; b) 60 tablets NDC: 72789-009-60; c) 90 tablets NDC: 72789-009-90; d) 180 tablets NDC: 72789-009-93 bottles, Rx only, Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake… · PD-Rx Pharmaceuticals, Inc. · 1683 bottlesClass IITerminatedmetformin HCL ER 750 mg Rx only Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 30 tablets NDC: 43063-902-30; b) 60 tablets NDC: 43063-902-60CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake… · PD-Rx Pharmaceuticals, Inc. · 125 bottlesClass IITerminated

September 2, 20202 recalls

July 22, 20202 recalls

How FDA classifies recalls

Class I: The drug may cause serious health consequences or death. Examples include the wrong drug in a bottle, a drug contaminated with bacteria, or a life-threatening allergen not declared on the label.

Class II: The drug may cause temporary or medically reversible adverse health consequences, or the probability of serious consequences is remote. Examples include a dissolution failure, a labeling error that affects dosing, or a nitrosamine impurity above the daily intake limit.

Class III: Use of the drug is unlikely to cause adverse health consequences, but the product violates FDA regulations. Examples include an incorrect tablet count per bottle, minor labeling issues, or packaging defects.

Definitions sourced from FDA Recall Classifications →

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.