Class I · High risk Terminated
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
Reason Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Meizitang Strong Version Botanical Slimming
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk Terminated
Magic Slim capsules
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk Terminated
Slim Xtreme Weight loss capsules
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk Terminated
Meizi Evolution Soft Gel Capsules
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine
Class I · High risk Terminated
SlimEasy Herbs Capsule
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine
Class I · High risk Terminated
Pill for weight reduction
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein
Class I · High risk Terminated
Super Fat Burning Bomb Capsules
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine
Class I · High risk Terminated
Fruta BIO 400 mg capsules
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Sibutramine and Phenolphthalein .
Class I · High risk Terminated
JIANFEIJINDAN Activity Girl Capsules
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared ingredient: N-di-desmethylsibutramine, an analog of sibutramine
Class I · High risk Terminated
REDUCE WEIGHT FRUTA PLANTA Capsules
Reason Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein.
Class I · High risk Terminated
PRO ArthMax Dietary Supplement tablets
Reason Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin
Class I · High risk Terminated
DOBUTamine Injection
Reason Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Class I · High risk Terminated
Xzen Platinum
Reason Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk Terminated
ExtenZe 600 mg
Reason Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk Terminated
Magic For Men
Reason Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk Terminated
MiracleZEN Platinum
Reason Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk Terminated
Sexy Monkey
Reason Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk Terminated
Boost Ultra
Reason Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk Terminated
Xzone Gold
Reason Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.
Class I · High risk Terminated
Burn 7 Capsules
Reason Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
Class I · High risk Terminated
Lidocaine HCl Injection
Reason Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.
Class I · High risk Terminated
MINERAL IV Injection
Reason Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis
Class I · High risk Terminated
Calcium Gluconate 10% for Injection
Reason Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination found in Calcium Gluconate saturated solution that was observed upon drawing the vial contents into a syringe.
Class I · High risk Terminated
Dream Body Slimming Capsule
Reason Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.