Class II · Moderate risk
exchange select
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
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
Vancomycin HCL
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
Vancomycin HCI
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
Vancomycin HCI
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
norepinephrine Bitartrate
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
norepinephrine Bitartrate
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
Clonidine Transdermal System
CGMP Deviations: use of an unapproved raw material
Class II · Moderate risk
traMADol Hydrochloride Tablets
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.07%
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Class II · Moderate risk
Albuterol Sulfate Inhalation Solution
Labelling: Illegible label
Class II · Moderate risk
Xanax XR
Failed Dissolution Specifications
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
Octreotide Acetate for Injectable Suspension
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Class II · Moderate risk
CUROSURF (poractant alfa)
Lack of Assurance of Sterility
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Class II · Moderate risk
Meclizine Hydrochloride Tablets
Failed tablet specifications.
Class II · Moderate risk
Buprenorphine Hydrochloride
Crystallization; identified as Buprenorphine free base
Class II · Moderate risk
Lanreotide Injection
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Class II · Moderate risk
Lanreotide Injection
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Class II · Moderate risk
5% Dextrose Injection
Lack of Assurance of Sterility