Class II · Moderate risk Ongoing
Isotretinoin Capsules
Reason Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
FDA Drug Recalls
17,898 recalls, newest first
Class III · Low risk Completed
Nexlizet
Reason Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules USP
Reason CGMP Deviations
Class II · Moderate risk Terminated
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Reason Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
Class II · Moderate risk Completed
Methylergonovine Maleate Tablets
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Digoxin Tablets
Reason Failed Impurities/Degradation Specifications
Class I · High risk Ongoing
Aruba Aloe Hand Sanitizer Gel
Reason Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class I · High risk Ongoing
Alcoholada Gel
Reason Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class II · Moderate risk Ongoing
fentaNYL Citrate 2
Reason Lack of Assurance of Sterility: leaking bags
Class II · Moderate risk Terminated
Lactated Ringer's Injection USP
Reason Lack of assurance of sterility: bags have the potential to leak..
Class I · High risk Terminated
Vancomycin Hydrochloride for Oral Solution
Reason Superpotent Drug: Due to overfilling of drug powder
Class II · Moderate risk Terminated
Rifampin Capsules USP
Reason Subpotent Drug
Class II · Moderate risk Terminated
VCF Vaginal Contraceptive Film
Reason cGMP Diviations
Class I · High risk Ongoing
Honey Manuka Bunny Love
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Alphastrip Male Performance Enhancer
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
The GOAT SUBLINGUAL STRIP
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Silverback Xxx Power Male Enhancement
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
libigrow RED DRAGON+
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
GoHARD 25000
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Pink Pussycat Honey
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Samurai-X Honey 6800
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Flower Power
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Weiner Boner Honey
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk Ongoing
Spanish Fly 22K capsules
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.