Class II · Moderate risk Terminated
CoEnzymeQ10 25mg/mL
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Biotin Suspension 10mg/mL
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
B-complex
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Ascorbic Acid
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class III · Low risk Terminated
Fabior
Reason Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Class III · Low risk Terminated
Tramadol Hydrochloride 50 mg tablets
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class II · Moderate risk Terminated
Estradiol Vaginal Inserts
Reason Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Class III · Low risk Terminated
Indomethacin Capsules USP
Reason Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
Class I · High risk Terminated
All Alka-Seltzer Plus¿ packages with a full front panel instant…
Reason Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.
Class III · Low risk Terminated
buPROPion HCl Extended-Release Tablets
Reason Failed Dissolution Specifications; during stability testing
Class III · Low risk Terminated
buPROPion HCl Extended-Release Tablets
Reason Failed Dissolution Specifications; during stability testing
Class III · Low risk Terminated
Triamcinolone Acetonide Lotion
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class III · Low risk Terminated
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal
Reason 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 Terminated
Red Zone Xtreme 3000 Capsules
Reason 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 Terminated
E-Z-Paste Barium Sulfate Esophageal Cream
Reason Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Class III · Low risk Terminated
Clocortolone Pivalate Cream
Reason Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Class II · Moderate risk Terminated
Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag
Reason Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk Terminated
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag
Reason Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk Terminated
Sermorelin Acetate
Reason Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk Terminated
Oxytocin USP
Reason Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk Terminated
Morphine Sulfate USP Milled
Reason Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Class III · Low risk Terminated
Decitabine for Injection
Reason Failed impurities/degradation specifications: Failure to water content and impurity
Class III · Low risk Terminated
Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL…
Reason 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 Terminated
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
methylPREDNISolone Sodium Succinate for Injection
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.