Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Diabetes Medication Recalls

Recalls of metformin and other drugs used to control blood sugar - metformin extended-release was recalled over the same nitrosamine impurity as valsartan.

161 recalls in this category, newest first.

Class II · Moderate risk

Pioglitazone HCL

Labeling: Label Mixup: PIOGLITAZONE HCL, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: DOXYCYCLINE MONOHYDRATE, Capsule, 100 mg, NDC 49884072703, Pedigree: AD52778_25, EXP: 5/20/2014; LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: W003263, EXP: 6/17/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-835-2014
Class II · Moderate risk

sitaGLIPtin PHOSPHATE

Labeling: Label Mixup: sitaGLIPtin PHOSPHATE, Tablet, 50 mg may be potentially mis-labeled as one of the following drugs: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62992_1, EXP: 5/23/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: W002860, EXP: 6/7/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-774-2014
Class II · Moderate risk

GLIMEPIRIDE Tablet

Labeling:Label Mixup; GLIMEPIRIDE, Tablet, 1 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD73525_4, EXP: 5/30/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-622-2014
Class II · Moderate risk

metFORMIN HCl Tablet 500 mg

Labeling: Label Mixup; metFORMIN HCl Tablet, 500 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD32742_1, EXP: 5/1/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-528-2014
Class II · Moderate risk

Glimepiride Tablets USP

Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.

Terminated Failed specification Qualitest Pharmaceuticals NDC 0603-3745-21 D-298-2013
Class II · Moderate risk

Kombiglyze XR

Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.

Terminated Labeling / mix-up Bristol-myers Squibb Company D-019-2013
Class II · Moderate risk

Kombiglyze XR

Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly labeled as Kombiglyze XR 2.5mg/1000mg on the external package carton, whereas the contents were Kombiglyze XR 5 mg/500 mg blister packaged tablets. The individual blister units are labeled correctly.

Terminated Labeling / mix-up Bristol-myers Squibb Company D-018-2013
Class II · Moderate risk

Humulin-R Insulin

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1532-2012
Class II · Moderate risk

Insulin

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1547-2012
Class II · Moderate risk

Metformin Hydrochloride Tablets

Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.

Terminated Particulate / foreign matter Zydus Pharmaceuticals USA Inc NDC 68382-030-10 D-1428-2012
Class I · High risk

metFORMIN ER Tablets

Labeling: Label Mix up; product labeled did not indicated Extended Release

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 53746-178-01 D-1448-2014