Class I · High risk
Methylprednisolone Acetate
Non-Sterility
FDA Drug Recalls
49 recalls · Class I, newest first
Class I · High risk
Methylprednisolone Acetate
Non-Sterility
Class I · High risk
Hydrocodone Bitartrate and Acetaminophen Tablets USP
Superpotent (Multiple Ingredient) Drug: There is the potential for oversized and superpotent tablets.
Class I · High risk
SLIM XTREME Herbal Slimming Capsule
Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
Class I · High risk
HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS
Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Class I · High risk
0.9% Sodium Chloride Injection
Presence of Particulate Matter; product may contain fibrous material
Class I · High risk
BiCNU (Carmustine for injection)
Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot.
Class I · High risk
Reumofan Plus Tablets
Marketed without an approved NDA/ANDA: Samantha Lynn Inc. is recalling Reumofan Plus Tablets because it contains undeclared drug ingredients making it an unapproved drug.
Class I · High risk
Mojo Nights for Her
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
Class I · High risk
Mojo Nights
Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs.
Class I · High risk
HYDROmorphone HCl Injection
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
Class I · High risk
Trastuzumab Kit containing 1 vial Trastuzumab
Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for investigational use has the potential to contain glass particulates.
Class I · High risk
Z-ROCK All Natural Male Supplement. 1 capsule blister pack
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Class I · High risk
X-ROCK 3 Day Pill For Men
Marketed Without an Approved NDA/ANDA: Products tested positive for Sildenafil and analogs of Sildenafil.
Class I · High risk
Vecuronium Bromide for Injection
Presence of Particulate Matter
Class I · High risk
V Maxx Rx
Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs.
Class I · High risk
a) Firminite 805 mg is packaged in 2 count
Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs.
Class I · High risk
HYDROmorphone HCl Injection
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
Class I · High risk
X-ROCK For Men
Marketed Without an Approved NDA/ANDA: product tested positive for PDE-5 Sildenafil and PDE-5 Hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analog of sildenafil, an FDA approved prescription drug for Erectile Dysfunction (ED).
Class I · High risk
Morphine Sulfate Injection
Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL
Class I · High risk
Blue Male Enhancement Pill
Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug
Class I · High risk
Japan Weight Loss Blue Capsules
Marketed Without an Approved ANDA/NDA: presence of sibutramine
Class I · High risk
Man King Capsules
Marketed Without an Approved ANDA/NDA: presence of sildenafil.
Class I · High risk
Hard Ten Days Capsule
Marketed Without an Approved ANDA/NDA: presence of sildenafil