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FDA Drug Recalls

17,898 recalls, newest first

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 III · Low risk Ongoing Mar 16, 2023

Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufactured for…

Reason Labeling; Incorrect NDC number on outer carton of product.

Focus Health Group Inc D-0535-2023

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

Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc…

Reason CGMP Deviations: Discoloration

Hetero USA Inc NDC 31722-713-10 D-0530-2023

Class I · High risk Ongoing Mar 13, 2023

Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc…

Reason Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged…

Camber Pharmaceuticals Inc. NDC 31722-629-21 D-0567-2023

Class II · Moderate risk Terminated Mar 13, 2023

Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-0431-90, Packaged and Distributed By: Direct Rx…

Reason cGMP deviations

Direct Rx NDC 61919-0431-90 D-0486-2023

Class II · Moderate risk Terminated Mar 13, 2023

Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC…

Reason cGMP deviations

Direct Rx NDC 61919-0446-30 D-0485-2023

Class II · Moderate risk Terminated Mar 13, 2023

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle…

Reason cGMP deviations

Direct Rx NDC 61919-0688-30 D-0484-2023

Class II · Moderate risk Terminated Mar 13, 2023

Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0710-90 Packaged and Distributed By: Direct Rx…

Reason cGMP deviations

Direct Rx NDC 61919-0710-90 D-0483-2023

Class II · Moderate risk Terminated Mar 13, 2023

Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0250-30; b) 90-count bottle, NDC…

Reason cGMP deviations

Direct Rx NDC 61919-0250-30 D-0482-2023

Class II · Moderate risk Terminated Mar 13, 2023

Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC…

Reason cGMP deviations

Direct Rx NDC 61919-0488-30 D-0481-2023

Class II · Moderate risk Terminated Mar 13, 2023

Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0723-30; b) 90-count bottle, NDC…

Reason cGMP deviations

Direct Rx NDC 61919-0723-30 D-0480-2023

Class II · Moderate risk Terminated Mar 13, 2023

Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx…

Reason cGMP deviations

Direct Rx NDC 72189-0364-30 D-0479-2023

Class II · Moderate risk Terminated Mar 13, 2023

Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct…

Reason cGMP deviations

Direct Rx NDC 72189-0364-30 D-0478-2023

Class II · Moderate risk Terminated Mar 13, 2023

Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx

Reason cGMP deviations

Direct Rx NDC 61919-0733-90 D-0477-2023

Class II · Moderate risk Terminated Mar 13, 2023

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle…

Reason cGMP deviations

Direct Rx NDC 61919-0009-30 D-0476-2023

Class II · Moderate risk Ongoing Mar 10, 2023

Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…

Reason Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc NDC 68968-5555-3 D-0473-2023

Class II · Moderate risk Ongoing Mar 10, 2023

Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…

Reason Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc NDC 68968-5554-3 D-0472-2023

Class II · Moderate risk Ongoing Mar 10, 2023

Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…

Reason Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc NDC 68968-5553-3 D-0471-2023

Class II · Moderate risk Ongoing Mar 10, 2023

Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC…

Reason Defective Delivery System: Out of specification for shear.

Noven Pharmaceuticals Inc NDC 68968-5552-3 D-0470-2023

Class III · Low risk Terminated Mar 9, 2023

Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured by: Sun Pharmaceutical Industries Limited, Survey…

Reason Failed Content Uniformity Specifications

Sun Pharmaceutical Industries INC NDC 47335-0063-86 D-0474-2023

Class II · Moderate risk Terminated Mar 9, 2023

JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles…

Reason Labeling: Label Mix-up

Boehringer Ingelheim Pharmaceuticals, Inc. NDC 0597-0153-30 D-0468-2023