Class I · High risk Terminated
Thin and Slim Fataway Ultimate Stack with Chromium
Reason Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection
Reason Subpotent Drug
Class I · High risk Terminated
fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection
Reason Subpotent Drug
Class I · High risk Terminated
fentaNYL citrate in 0.9% Sodium Chloride Injection
Reason Subpotent Drug
Class I · High risk Terminated
fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection
Reason Subpotent Drug
Class I · High risk Terminated
fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection
Reason Subpotent Drug
Class I · High risk Terminated
Atropine Sulfate Injection Solution
Reason Subpotent Drug
Class I · High risk Terminated
fentaNYL citrate in 0.9% Sodium Chloride Injection
Reason Subpotent Drug
Class I · High risk Terminated
Prolotherapy with Phenol
Reason Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Class I · High risk Terminated
Prolotherapy with Phenol
Reason Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Class I · High risk Terminated
KABOOM action strips
Reason Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.
Class I · High risk Terminated
LiDa DAIDAIHUA
Reason Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.
Class I · High risk Terminated
Adrucil
Reason Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Class I · High risk Terminated
0.9% Sodium Chloride Injection USP
Reason Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Class I · High risk Terminated
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container
Reason Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Class I · High risk Terminated
fentaNYL Citrate
Reason Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
Class I · High risk Ongoing
Akttive High Performance Fat Burner Gold dietary supplement capsules
Reason Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.
Class I · High risk Ongoing
Zero Xtreme High Performance Fat Burner capsules
Reason Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Class I · High risk Terminated
PYROLA Advanced Joint Formula capsules
Reason Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared diclofenac, a prescription non-steroidal anti-inflammatory drug, and chlorpheniramine, an over-the-counter antihistimine, making this an unapproved drug.
Class I · High risk Terminated
Smart Lipo Dietary Supplement capsules
Reason Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Class I · High risk Terminated
Smart Lipo Dietary Supplement capsules
Reason Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Class I · High risk Terminated
Morphine Sulfate
Reason Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
Class I · High risk Terminated
Adrucil
Reason Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Class I · High risk Terminated
Cytarabine Injection 100 mg/5 mL
Reason Presence of Particulate Matter
Class I · High risk Terminated
Bupivacaine Hydrochloride Inj.
Reason Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.