Class I · High risk
Human Chorionic Gonadotropin
Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.
FDA Drug Recalls
21 recalls, newest first
Class I · High risk
APEXXX tablets
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.
Class I · High risk
Vitamin Supplement
Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).
Class II · Moderate risk
Screenses Color Sunscreen
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Screenses Color Sunscreen Tinted facial make-up compact
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 50
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Deodorant for Women
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 50
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Salises Facial Moisturizing Acne Treatment Gel
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Dryses Aluminum Chlorohydrate Antiperspirant Solution
cGMP Deviations; product does not comply with cGMP requirements
Class III · Low risk
Amidate (Etomidate Injection, USP)
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
Class I · High risk
MIRACLE DIET 30 capsules
Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.
Class I · High risk
MIRACLE ROCK 48 capsules
Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.
Class II · Moderate risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
Class I · High risk
Akttive High Performance Fat Burner Gold dietary supplement capsules
Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.
Class I · High risk
Zero Xtreme High Performance Fat Burner capsules
Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization; identified as calcium salt of Ketorolac
Class II · Moderate risk
KETOROLAC Tromethamine Inj.
Crystallization; identified as calcium salt of Ketorolac