Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
FDA Drug Recalls
354 recalls, newest first
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class I · High risk
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk
Javygtor (sapropterin dihydrochloride)
Sub-potent Drug; powder discoloration associated with decreased potency
Class II · Moderate risk
Isotretinoin Capsules
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
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 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 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.
Class I · High risk
GoHARD 25000
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Pink Pussycat Honey
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Samurai-X Honey 6800
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Flower Power
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Weiner Boner Honey
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class I · High risk
Spanish Fly 22K capsules
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.
Class II · Moderate risk
Infumorph (Preservative-free Morphine Sulfate Sterile Solution)
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Class I · High risk
Treprostinil Injection
Presence of Particulate Matter.
Class II · Moderate risk
Febuxostat Tablets 80mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Febuxostat Tablets 40mg
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.