Class III · Low risk
Azacitidine for Injection 100mg/vial Lyophilized Powder
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
FDA Drug Recalls
86 recalls · Class III, newest first
Class III · Low risk
Lamotrigine Tablets
Labeling: Label Error on Declared Strength
Class III · Low risk
Tacrolimus Ointment
Defective Container: Tube split from side seam
Class III · Low risk
Crest 3D White Fluoride Anticavity Toothpaste
Labeling: Missing label: the product tube was missing a label and contained a different formulation.
Class III · Low risk
Juice Beauty
Failed Dissolution Specifications
Class III · Low risk
Juice Beauty
Failed Dissolution Specifications
Class III · Low risk
Aspirin and Extended-Release Dipyridamole Capsules
Failed Tablet/Capsule Specification : Capsule breakage
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class III · Low risk
Mometasone Furoate
Defective Container
Class III · Low risk
Alprostadil Injection USP 500 mcg/mL
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class III · Low risk
Tivicay (dolutegravir)
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Xiidra (lifitegrast ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Sirolimus Oral Solution
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Class III · Low risk
Nitrofurantoin Capsules
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class III · Low risk
Higher Education Make Out Ready Vegan Lip Balm
Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablet
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablet
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Class III · Low risk
Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic…
Subpotent drug: Low OOS for menthol content at the three month room temperature.
Class III · Low risk
Lidocaine Hydrochloride Oral Topical Solution
Failed viscosity specification - product was below specificcation
Class III · Low risk
Phenobarbital Elixir
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
Class III · Low risk
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial
cGMP deviations: Temperature abuse