Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

FDA Drug Recalls

775 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

PrimeZEN Black 6000 capsule

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Terminated Chemical / undeclared Volt Candy Wholesale Club D-0453-2023
Class II · Moderate risk

Allergy Relief

Failed Impurities/Degradation Specifications

Terminated Impurity / degradation L. Perrigo Company NDC 36800-691-39 D-0912-2023
Class II · Moderate risk

Picnic

Failed Impurities/Degradation Specifications

Terminated Impurity / degradation L. Perrigo Company D-0911-2023
Class II · Moderate risk

allergy relief

Failed Impurities/Degradation Specifications

Terminated Impurity / degradation L. Perrigo Company NDC 11673-617-22 D-0910-2023
Class II · Moderate risk

allergyrelief

Failed Impurities/Degradation Specifications

Terminated Impurity / degradation L. Perrigo Company NDC 56062-847-39 D-0909-2023
Class II · Moderate risk

allergy relief

Failed Impurities/Degradation Specifications

Terminated Impurity / degradation L. Perrigo Company NDC 79481-0847-0 D-0906-2023
Class II · Moderate risk

aller-ease

Failed Impurities/Degradation Specifications

Terminated Impurity / degradation L. Perrigo Company NDC 55301-847-39 D-0904-2023
Class II · Moderate risk

Allergy Relief

Failed Impurities/Degradation Specifications

Terminated Impurity / degradation L. Perrigo Company NDC 69842-0914-39 D-0903-2023
Class II · Moderate risk

Allergy Relief

Failed Impurities/Degradation Specifications

Terminated Impurity / degradation L. Perrigo Company NDC 72476-847-22 D-0902-2023
Class II · Moderate risk

Allergy

Failed Impurities/Degradation Specifications

Terminated Impurity / degradation L. Perrigo Company NDC 72288-847-39 D-0900-2023
Class II · Moderate risk

rOPINIRole Tablets USP 3 mg*

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-236-01 D-0429-2023
Class II · Moderate risk

rOPINIRole Tablets USP 2 mg*

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-235-01 D-0428-2023
Class II · Moderate risk

rOPINIRole Tablets USP 1 mg*

CGMP Deviations: recalling drug products following an FDA inspection.

Terminated cGMP deviation Accord Healthcare, Inc. NDC 16729-234-01 D-0427-2023

Recalls by year