US Drug Recall Register

FDA Drug Recalls

14,450 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class II · Moderate risk Terminated

Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg

Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

Sun Pharmaceutical Industries, Inc. D-1390-2019
Class II · Moderate risk Terminated

Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/…

Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

Sun Pharmaceutical Industries, Inc. D-1389-2019
Class II · Moderate risk Terminated

Allergy Relief D

Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

Sun Pharmaceutical Industries, Inc. D-1388-2019
Class II · Moderate risk Terminated

Allergy Relief D

Reason Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: elevated substance results that were reported above or near the specification limit

Sun Pharmaceutical Industries, Inc. D-1387-2019
Class II · Moderate risk Terminated

Estradiol Vaginal Inserts USP 10 mcg

Reason Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.

Glenmark Pharmaceuticals Inc., USA NDC 68462-711-71 D-1340-2019
Class II · Moderate risk Terminated

Gericare Geri-Tussin DM

Reason cGMP Deviations: Products may have microbial contamination.

Geritrex, LLC NDC 57896-660-16 D-1526-2019
Class II · Moderate risk Terminated

Ritussin DM Double Strength

Reason cGMP Deviations: Products may have microbial contamination.

Geritrex, LLC D-1525-2019
Class II · Moderate risk Terminated

Ritussin DM Children & Adults

Reason cGMP Deviations: Products may have microbial contamination.

Geritrex, LLC NDC 53807-409-04 D-1521-2019
Class II · Moderate risk Terminated

Diphenhydramine Oral Liquid Alcohol Free

Reason cGMP Deviations: Products may have microbial contamination.

Geritrex, LLC NDC 53807-204-04 D-1520-2019
Class II · Moderate risk Terminated

Zileuton Extended-Release Tablets

Reason Failed Dissolution Specifications: Out of specification result for dissolution.

Chiesi USA, Inc. NDC 66993-485-32 D-1342-2019
Class II · Moderate risk Terminated

Zyflo Cr

Reason Failed Dissolution Specifications: Out of specification result for dissolution.

Chiesi USA, Inc. NDC 10122-902-12 D-1341-2019
Class II · Moderate risk Terminated

Memorial Central TPN. Rx Only

Reason Lack of sterility assurance.

Surgery Pharmacy Services Inc D-0610-2020
Class II · Moderate risk Terminated

Sn-Pyrophosphate Kit

Reason Lack of Processing Controls.

Synthetopes Inc D-1406-2019
Class II · Moderate risk Terminated

Sn-Tetrofosmin Kit 5.0 mL

Reason Lack of Processing Controls.

Synthetopes Inc D-1405-2019
Class II · Moderate risk Terminated

Sn-DTPA Kit 10 mg

Reason Lack of Processing Controls.

Synthetopes Inc D-1404-2019
Class II · Moderate risk Terminated

Sn-d

Reason Lack of Processing Controls.

Synthetopes Inc D-1403-2019
Class II · Moderate risk Terminated

Sn-Mertiatide Kit

Reason Lack of Processing Controls.

Synthetopes Inc D-1401-2019
Class II · Moderate risk Terminated

Sn-DMSA solution

Reason Lack of Processing Controls.

Synthetopes Inc D-1400-2019
Class II · Moderate risk Terminated

Pentreotide

Reason Lack of Processing Controls.

Synthetopes Inc D-1399-2019