Class I · High risk
Linezolid Injection 600 mg/300 mL
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
FDA Drug Recalls
80 recalls · Class I, newest first
Class I · High risk
BodySlim Herbal Advanced technology & Strong formula capsules
Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
Class I · High risk
Pantoprazole Sodium for Injection
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Class I · High risk
BLUE PEARL capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Class I · High risk
Hard Times For Men capsules
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
Class I · High risk
Nexterone (amiodarone HCl)
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Class I · High risk
GERICARE Eyewash
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Class I · High risk
Midazolam Injection
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Class I · High risk
diphenoxylate hydrochloride and atropine sulfate tablets
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class I · High risk
Enhanced Vegetal Vigra 200 mg Capsules
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
Class I · High risk
grande X 5800 capsule
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk
FIFTY SHADES 6000 capsule
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk
PapaZen 3300 capsule
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk
RHINO 7 Platinum 5000
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class I · High risk
Intralipid 20%
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
Class I · High risk
Activase (alteplase)
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class I · High risk
Vancomycin Hydrochloride for Injection
Presence of Particulate Matter: glass particulate found in vial
Class I · High risk
PIYANPING Anti-Itch
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
Class I · High risk
Pravastatin Sodium Tablets
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Class I · High risk
Lorazepam Oral Concentrate
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Class I · High risk
Natural Herbal Coffee Ampt
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.
Class I · High risk
LaBri's Body Health XPLODE 30 capsules Exclusively distribute…
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Class I · High risk
LaBri's Body Health Atomic 60 Capsules Exclusively distributed…
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Class I · High risk
Super Panther 7K Capsules 1250 mg blend
Marketed without an Approved NDA/ANDA;FDA analysis found product to be tainted with sildendafil and tadalafil
Class I · High risk
New Kopi Jantan Tradisional Natural Herbs Coffee
Marketed without an approved NDA/ANDA: presence of undeclared desmethyl carbodenafil and undeclared milk.