FDA Drug Recalls

774 recalls, newest first

Class II · Moderate risk Terminated Feb 7, 2023

Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000…

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

Accord Healthcare, Inc. NDC 16729-044-15 D-0371-2023

Class II · Moderate risk Terminated Feb 7, 2023

Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle, NDC…

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

Accord Healthcare, Inc. NDC 16729-283-10 D-0370-2023

Class II · Moderate risk Terminated Feb 7, 2023

Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count…

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

Accord Healthcare, Inc. NDC 16729-282-10 D-0369-2023

Class II · Moderate risk Terminated Feb 7, 2023

Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count…

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

Accord Healthcare, Inc. NDC 16729-281-10 D-0368-2023

Class II · Moderate risk Terminated Feb 7, 2023

Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count…

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

Accord Healthcare, Inc. NDC 16729-280-10 D-0367-2023

Class II · Moderate risk Terminated Feb 7, 2023

Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-count…

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

Accord Healthcare, Inc. NDC 16729-279-10 D-0366-2023

Class II · Moderate risk Terminated Feb 7, 2023

Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-count…

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

Accord Healthcare, Inc. NDC 16729-278-10 D-0365-2023

Class II · Moderate risk Terminated Feb 6, 2023

Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601…

Reason Sub-Potent Drug: Out of specification for assay at the 24 month interval.

Alvogen, Inc NDC 47781-654-90 D-0353-2023

Class II · Moderate risk Terminated Feb 3, 2023

Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN…

Reason Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.

Leadiant Biosciences, Inc. NDC 57665-101-41 D-0327-2023

Class III · Low risk Terminated Feb 2, 2023

Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analgesic, NET…

Reason Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.

Advantice Health, Llc NDC 16864-670-01 D-0329-2023

Class III · Low risk Terminated Feb 1, 2023

BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured…

Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc D-0352-2023

Class III · Low risk Terminated Feb 1, 2023

Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container…

Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc D-0351-2023

Class III · Low risk Terminated Feb 1, 2023

Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container…

Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc D-0350-2023

Class III · Low risk Terminated Feb 1, 2023

Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container…

Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc D-0349-2023

Class II · Moderate risk Terminated Jan 31, 2023