Independent register of U.S. FDA drug recalls · updated Oct 11, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,535 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 II · Moderate risk

0.9% Sodium Chloride Injection

Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.

Completed Sterility / contamination B. Braun Medical Inc. NDC 0264-5802-10 D-0347-2023
Class II · Moderate risk

0.9% Sodium Chloride Injection

Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.

Completed Sterility / contamination B. Braun Medical Inc. NDC 0264-5802-00 D-0346-2023
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

Fentanyl 500mcg

Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

Ongoing Sterility / contamination Apollo Care NDC 71170-950-25 D-0487-2023
Class II · Moderate risk

Tacrolimus Capsules

Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.

Ongoing Particulate / foreign matter Dr. Reddy's Laboratories, Inc. NDC 55111-525-01 D-0330-2023
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