US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

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

Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and…

Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Coast Quality Pharmacy, LLC dba Anazao Health D-0584-2020
Class II · Moderate risk Terminated

Baclofen and Morphine Sulfate in all strengths

Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Coast Quality Pharmacy, LLC dba Anazao Health D-0582-2020
Class II · Moderate risk Terminated

Baclofen in all strengths

Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Coast Quality Pharmacy, LLC dba Anazao Health D-0581-2020
Class II · Moderate risk Terminated

Clonidine HCL/Hydromorphone HCL in all strengths

Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Coast Quality Pharmacy, LLC dba Anazao Health D-0580-2020
Class II · Moderate risk Terminated

Glutamine/Arginine/Carnitine in all strengths

Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Coast Quality Pharmacy, LLC dba Anazao Health D-0579-2020
Class II · Moderate risk Terminated

Clonidine HCL and Morphine Sulfate in all strengths

Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Coast Quality Pharmacy, LLC dba Anazao Health D-0578-2020
Class I · High risk Terminated

Milk of Magnesia USP

Reason Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.

Plastikon Healthcare LLC NDC 0904-6846-73 D-1879-2019
Class II · Moderate risk Terminated

Bevacizumab

Reason Lack of assurance of sterility.

Pacifico National, Inc. dba AmEx Pharmacy D-1850-2019
Class II · Moderate risk Terminated

Bevacizumab

Reason Lack of assurance of sterility.

Pacifico National, Inc. dba AmEx Pharmacy D-1849-2019
Class II · Moderate risk Terminated

Fexofenadine HCl Tablets

Reason Failed Impurities/Degradation Specifications

Preferred Pharmaceuticals, Inc D-1877-2019
Class II · Moderate risk Terminated

Ascorbic Acid Sterile Injection Solution

Reason Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source.

Atlas Pharmaceuticals, LLC NDC 71591-500-50 D-0144-2020
Class III · Low risk Terminated

Lamivudine Tablets

Reason Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.

American Health Packaging NDC 60687-362-21 D-1847-2019
Class III · Low risk Terminated

minolira

Reason Failed Dissolution Specifications:

EPI Health, LLC NDC 71403-102-05 D-0120-2020
Class II · Moderate risk Terminated

Entropic Labs SARM RAD-140

Reason Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)

Tuscano and Delucia Group (DBA Entropic Labs) D-0800-2020
Class II · Moderate risk Terminated

Allergy

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 53943-021-09 D-1874-2019
Class II · Moderate risk Terminated

Wal-Fex

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 0363-0097-55 D-1873-2019
Class II · Moderate risk Terminated

Allergy

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 58602-820-09 D-1872-2019
Class II · Moderate risk Terminated

Fexofenadine HCL Tablets USP

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC D-1871-2019
Class II · Moderate risk Terminated

Fexofenadine Hydrochloride Tablets USP

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 62011-0315-1 D-1870-2019
Class II · Moderate risk Terminated

Allergy Relief

Reason Failed Impurities/Degradation Specifications

Aurolife Pharma, LLC NDC 49035-995-62 D-1869-2019