US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Class II · Moderate risk Terminated

Fosphenytoin Sodium Injection

Reason Presence of Particulate Matter

Amneal Pharmaceuticals LLC D-0076-2018
Class II · Moderate risk Terminated

Daytrana

Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Noven Pharmaceuticals, Inc. NDC 68968-5553-3 D-1172-2017
Class II · Moderate risk Terminated

Daytrana

Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Noven Pharmaceuticals, Inc. NDC 68968-5555-3 D-1171-2017
Class II · Moderate risk Terminated

Daytrana

Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-1170-2017
Class II · Moderate risk Terminated

Daytrana

Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.

Noven Pharmaceuticals, Inc. NDC 68968-5552-3 D-1169-2017
Class II · Moderate risk Terminated

Doctor Manzanilla Cough & Cold

Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

Mid Valley Pharmaceutical D-1136-2017
Class II · Moderate risk Terminated

Doctor Manzanilla Allergy & Decongestant Relief

Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

Mid Valley Pharmaceutical D-1135-2017
Class II · Moderate risk Terminated

Choice Antibacterial Hand Soap

Reason GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.

Inopak Ltd D-0004-2018
Class II · Moderate risk Terminated

Mild Healthcare Antibacterial Hand Soap

Reason GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump.

Inopak Ltd D-0003-2018
Class II · Moderate risk Terminated

Option Systems Antibacterial Foaming Hand Wash

Reason GMP Deviations; potential bacterial contamination may have been introduced to products through a contaminated diaphragm pump

Inopak Ltd NDC 5031-431-02 D-0002-2018
Class II · Moderate risk Terminated

Ketorolac Trom 30 mg/mL Injection

Reason Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.

RemedyRepack Inc. NDC 61786-0741-01 D-1176-2017
Class II · Moderate risk Terminated

Levophed

Reason Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.

Pfizer Inc. NDC 0409-3375-04 D-1168-2017