Independent register of U.S. FDA drug recalls · updated Oct 12, 2026
RxRecalls Get alerts

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.

Class II · Moderate risk

fentaNYL Citrate Injection

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Terminated Stability / shelf life Pharmedium Services, LLC D-0038-2017
Class II · Moderate risk

fentaNYL Citrate Injection

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Terminated Stability / shelf life Pharmedium Services, LLC D-0037-2017
Class II · Moderate risk

fentaNYL Citrate

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Terminated Stability / shelf life Pharmedium Services, LLC D-0036-2017
Class II · Moderate risk

fentaNYL Citrate

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Terminated Stability / shelf life Pharmedium Services, LLC D-0035-2017
Class II · Moderate risk

fentaNYL Citrate Injection

Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.

Terminated Wrong potency / content Pharmedium Services, LLC D-0034-2017
Class II · Moderate risk

fentaNYL Citrate Injection

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Terminated Stability / shelf life Pharmedium Services, LLC NDC 61553-118-40 D-0033-2017
Class II · Moderate risk

ePHEDrine Sulfate

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Terminated Stability / shelf life Pharmedium Services, LLC D-0031-2017
Class II · Moderate risk

ePHEDrine Sulfate

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Terminated Stability / shelf life Pharmedium Services, LLC D-0030-2017
Class II · Moderate risk

ePHEDrine Sulfate

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Terminated Stability / shelf life Pharmedium Services, LLC D-0029-2017
Class II · Moderate risk

Buffered Lidocaine

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Terminated Stability / shelf life Pharmedium Services, LLC D-0028-2017
Class II · Moderate risk

Buffered Lidocaine

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Terminated Stability / shelf life Pharmedium Services, LLC D-0027-2017
Class II · Moderate risk

atropine Sulfate Injection

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Terminated Stability / shelf life Pharmedium Services, LLC D-0026-2017
Class II · Moderate risk

atropine Sulfate Injection

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

Terminated Stability / shelf life Pharmedium Services, LLC D-0025-2017
Class II · Moderate risk

biotene PBF Toothpaste

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Terminated Particulate / foreign matter GlaxoSmithkline Consmer Healthcare NDC 0135-0559-01 D-1320-2015
Class II · Moderate risk

biotene Gentle Mint Gel

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

Terminated Particulate / foreign matter GlaxoSmithkline Consmer Healthcare NDC 0135-0488-01 D-1317-2015
Class II · Moderate risk

Clonidine Hydrochloride Tablets

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

Terminated cGMP deviation Mutual Pharmaceutical Company, Inc. NDC 53489-217-01 D-1282-2015

Recalls by year