FDA Drug Recalls

948 recalls · Class II, newest first

Class II · Moderate risk Terminated Mar 17, 2023

Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Amerisource Health Services LLC NDC 68001-179-00 D-0759-2023

Class II · Moderate risk Terminated Mar 17, 2023

Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Amerisource Health Services LLC NDC 68001-178-00 D-0758-2023

Class II · Moderate risk Terminated Mar 17, 2023

Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Amerisource Health Services LLC NDC 68001-177-00 D-0757-2023

Class II · Moderate risk Ongoing Mar 17, 2023

Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA…

Reason Out of specification (OOS) for Spectroscopic Identification test by IR.

Ascend Laboratories, LLC D-0539-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-487-52 D-0554-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-473-87 D-0553-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-120-52 D-0552-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-383-52 D-0551-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-109-52 D-0550-2023

Class II · Moderate risk Ongoing Mar 16, 2023

BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-511-52 D-0549-2023

Class II · Moderate risk Ongoing Mar 16, 2023

Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN…

Reason CGMP Deviations

Northwind Pharmaceuticals LLC NDC 51655-946-52 D-0548-2023

Class II · Moderate risk Terminated Mar 16, 2023

Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by…

Reason Failed Dissolution Specifications: Out of specification dissolution results above specified values.

Amerisource Health Services LLC D-0536-2023

Class II · Moderate risk Completed Mar 15, 2023

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare…

Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Baxter Healthcare Corporation NDC 0941-0411-04 D-0543-2023

Class II · Moderate risk Completed Mar 15, 2023

Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II…

Reason Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

Baxter Healthcare Corporation NDC 0941-0409-07 D-0542-2023

Class II · Moderate risk Ongoing Mar 14, 2023

Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA…

Reason CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Ascend Laboratories, LLC NDC 67877-475-60 D-0534-2023

Class II · Moderate risk Ongoing Mar 14, 2023

Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA…

Reason CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Ascend Laboratories, LLC NDC 67877-474-60 D-0533-2023

Class II · Moderate risk Ongoing Mar 14, 2023