Class I · High risk
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Sub-potent Drug; powder discoloration associated with decreased potency
FDA Drug Recalls
18,003 recalls, newest first
Class I · High risk
Javygtor (sapropterin dihydrochloride)
Sub-potent Drug; powder discoloration associated with decreased potency
Class III · Low risk
Cyclophosphamide for Injection
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class III · Low risk
Cyclophosphamide for Injection
Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.
Class II · Moderate risk
Eyesaline
CGMP Deviations
Class I · High risk
Atovaquone Oral Suspension USP
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Class II · Moderate risk
Isotretinoin Capsules
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Class III · Low risk
NEXLIZET (bempedoic acid and ezetimibe)
Failed dissolution specifications: out-of-specification bempedoic acid dissolution at the 0-month timepoint.
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations
Class II · Moderate risk
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules
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
Methylergonovine Maleate Tablets
Failed Dissolution Specifications
Class III · Low risk
Digoxin Tablets
Failed Impurities/Degradation Specifications
Class I · High risk
Aruba Aloe Hand Sanitizer Gel
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class I · High risk
Alcoholada Gel
Chemical Contamination: Product manufactured with ethanol API that contains methanol
Class II · Moderate risk
fentaNYL Citrate 2
Lack of Assurance of Sterility: leaking bags
Class II · Moderate risk
Lactated Ringer's Injection USP
Lack of assurance of sterility: bags have the potential to leak..
Class I · High risk
Vancomycin Hydrochloride for Oral Solution
Superpotent Drug: Due to overfilling of drug powder
Class II · Moderate risk
Rifampin Capsules USP
Subpotent Drug
Class II · Moderate risk
VCF Vaginal Contraceptive Film
cGMP Diviations
Class I · High risk
Honey Manuka Bunny Love
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Alphastrip Male Performance Enhancer
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
The GOAT SUBLINGUAL STRIP
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Silverback Xxx Power Male Enhancement
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
libigrow RED DRAGON+
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.