Class III · Low risk
buPROPion HCl Extended-Release Tablets
Failed Dissolution Specifications; during stability testing
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class III · Low risk
buPROPion HCl Extended-Release Tablets
Failed Dissolution Specifications; during stability testing
Class III · Low risk
Triamcinolone Acetonide Lotion
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class III · Low risk
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Class I · High risk
Red Zone Xtreme 3000 Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
Class II · Moderate risk
E-Z-Paste Barium Sulfate Esophageal Cream
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Class III · Low risk
Clocortolone Pivalate Cream
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Class II · Moderate risk
Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk
Sermorelin Acetate
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk
Oxytocin USP
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk
Morphine Sulfate USP Milled
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Class III · Low risk
Decitabine for Injection
Failed impurities/degradation specifications: Failure to water content and impurity
Class III · Low risk
Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL…
Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Class III · Low risk
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
methylPREDNISolone Sodium Succinate for Injection
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II · Moderate risk
methylPREDNISolone Sodium Succinate for Injection
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II · Moderate risk
methylPREDNISolone Sodium Succinate for Injection
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class III · Low risk
Flucanazole Injection
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Class II · Moderate risk
RANITIDINE Tablets
Failed Stability Specifications
Class II · Moderate risk
Evamist (estradiol transdermal spray)
Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
Class II · Moderate risk
Coppertone Kids Sunscreen Spray
Labeling: Label mix-up
Class III · Low risk
Lynparza (olaparib)
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Class III · Low risk
labetalol HCl injection 20 mg/4 mL
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018