US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

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

ProSol - sulfite-free

Reason Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).

Baxter Healthcare Corp NDC 0338-0499-06 D-1542-2014
Class II · Moderate risk Terminated

CYTARAbine for Injection USP

Reason Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.

Ben Venue Laboratories Inc NDC 55390-808-01 D-1543-2014
Class II · Moderate risk Terminated

0.9% Sodium Chloride Injection

Reason Lack of Assurance of Sterility; complaints of mold in the overpouch

Baxter Healthcare Corp. NDC 0338-0049-03 D-1583-2014
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason Presence of Foreign Substance; tablets may contain stainless steel metal particulates

Mckesson Packaging Services NDC 63739-644-10 D-1515-2014
Class II · Moderate risk Terminated

Alprazolam Tablets

Reason Presence of Foreign Substance; tablets may contain stainless steel metal particulates

Sandoz Incorporated NDC 0781-1061-10 D-1509-2014
Class II · Moderate risk Terminated

Wockhardt Metoprolol Succinate Extended-Release Tablets

Reason Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.

Wockhardt Usa Inc. NDC 64679-737-02 D-1541-2014
Class II · Moderate risk Terminated

Fagron

Reason Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

Fagron, Inc NDC 51552-1285-8 D-1498-2014
Class II · Moderate risk Terminated

Fagron

Reason Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

Fagron, Inc NDC 51552-0919-8 D-1497-2014
Class II · Moderate risk Terminated

Fagron

Reason Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

Fagron, Inc NDC 51552-1205-6 D-1496-2014
Class II · Moderate risk Terminated

Tetrahydrozoline Hydrochloride

Reason CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.

Spectrum Laboratory Products D-0255-2015
Class II · Moderate risk Terminated

All sterile products within expiry

Reason Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.

Unique Pharmaceutical, Ltd D-0012-2015
Class II · Moderate risk Terminated

Tetrahydrozoline HCL

Reason CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.

SST Corporation D-1517-2014
Class II · Moderate risk Terminated

Daytrana

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.

Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-1608-2014
Class II · Moderate risk Terminated

Benicar HCT Tablets

Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.

Daiichi Sankyo Pharma Development NDC 65597-107-30 D-1508-2014
Class II · Moderate risk Terminated

Benicar HCT Tablets

Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.

Daiichi Sankyo Pharma Development NDC 65597-106-30 D-1507-2014
Class II · Moderate risk Terminated

Benicar Tablets

Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.

Daiichi Sankyo Pharma Development NDC 65597-104-30 D-1506-2014
Class II · Moderate risk Terminated

Welchol Tablets

Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Daiichi Sankyo Pharma Development NDC 65597-701-18 D-1505-2014
Class II · Moderate risk Terminated

Tribenzor Tablets

Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Daiichi Sankyo Pharma Development NDC 65597-116-30 D-1504-2014
Class II · Moderate risk Terminated

Benicar HCT Tablets

Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Daiichi Sankyo Pharma Development NDC 65597-105-30 D-1503-2014
Class II · Moderate risk Terminated

Benicar Tablets

Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Daiichi Sankyo Pharma Development NDC 65597-103-30 D-1502-2014
Class II · Moderate risk Terminated

Azor Tablets

Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Daiichi Sankyo Pharma Development NDC 65597-113-30 D-1501-2014
Class II · Moderate risk Terminated

Losartan Potassium and Hydrochlorothiazide Tablets

Reason Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.

Jubilant Cadista Pharmaceuticals Inc. NDC 59746-339-90 D-1500-2014
Class II · Moderate risk Terminated

Clonidine HCL

Reason cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

Gyma Laboratories Of Amer,Inc D-0024-2015
Class II · Moderate risk Terminated

Clonidine Base Micronized

Reason cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

Gyma Laboratories Of Amer,Inc NDC 12660-0503-01 D-0023-2015