Class II · Moderate risk Ongoing
Natural Pain Relieving Cream
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
Pain Wizard
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules
Reason Failed Dissolution Specifications
Class III · Low risk Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free
Reason Out of specification for assay
Class II · Moderate risk Ongoing
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile…
Reason Subpotent Drug
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class III · Low risk Ongoing
Abilify
Reason Cross Contamination with Other Products
Class I · High risk Ongoing
Sapropterin Dihydrochloride Powder for Oral Solution 100mg
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Class I · High risk Ongoing
Javygtor
Reason Sub-potent Drug; powder discoloration associated with decreased potency
Class II · Moderate risk Ongoing
Isotretinoin Capsules
Reason Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
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 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 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.