Class II · Moderate risk
HydrOXYzine HCl Tablets
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01%
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01%
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class III · Low risk
DermOtic Oil
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Class II · Moderate risk
GREENSTONE BRAND fluconazole for Oral Suspension
Defective Container: Tamper evident ring failures discovered on some bottles.
Class III · Low risk
Triamcinolone Acetonide Cream USP
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Class II · Moderate risk
Oxcarbazepine Tablets
Failed Tablet Specifications: Broken Tablets Present.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Class III · Low risk
Carisoprodol Tablets
Failed Impurity/degradation Specification
Class II · Moderate risk
Metformin HCl Extended-Release Tablets
Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER
Class III · Low risk
Suprax
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class III · Low risk
Suprax
Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station.
Class I · High risk
Meizitang Strong Version Botanical Slimming
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk
Magic Slim capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk
Slim Xtreme Weight loss capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk
Meizi Evolution Soft Gel Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk
SlimEasy Herbs Capsule
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine
Class I · High risk
Pill for weight reduction
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein
Class I · High risk
Super Fat Burning Bomb Capsules
Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine