Class I · High risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
FDA Drug Recalls
1,463 recalls · Class I, newest first
Class I · High risk
Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution
Non-Sterility: Customer complaints of mold in the product after use and handling due to the fact that the preservative used in the lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution may not be effective through expiry.
Class I · High risk
Aminosyn II
Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
Class I · High risk
Cubicin (daptomycin for injection)
Presence of Particulate Matter; Glass particulates observed in vials
Class I · High risk
PRO POWER MAX Natural Energy Enhancer
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil and tadalafil
Class I · High risk
72hp Maximum Potency Male Sexual Enhancement
Marketed without an Approved NDA/ANDA: products were found to contain undeclared sildenafil
Class I · High risk
Evil Root 1200 mg
Marketed without an Approved NDA/ANDA: product found to contain undeclared sildenafil
Class I · High risk
J.R. Jack Rabbit All Natural Herbal Supplement
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that J.R. Jack Rabbit Male Enhancement product was found to contain two undeclared active pharmaceutical ingredients: sildenafil and tadalafil.
Class I · High risk
CALCIUM GLUCONATE 2 gm
Non Sterility: Microbial contamination
Class I · High risk
Bethel Advance
Marketed Without An Approved NDA/ANDA: FDA analyses detected the presence of phenolphthalein, N-di-Desmethylsibutramine, and trace amounts of sibutramine and N-Desmethylsibutramine. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Class I · High risk
Quick Thin
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine, N-Desmethylsibutramine and phenolphthalein. Sibutramine and phenolphthalein were previously available drug products but were removed from the U.S. market making these products unapproved new drugs.
Class I · High risk
BEST Slim
Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new drug.
Class I · High risk
Multi-Mineral capsules
Marketed Without An Approved NDA/ANDA: New York State Department of Health analysis of this product found it to contain undeclared steroid-like substances making it an unapproved new drug.
Class I · High risk
B-50 capsules
Marketed Without An Approved NDA/ANDA: FDA analysis of this product found it to contain undeclared steroids and steroid-like substances making this an unapproved new drug.
Class I · High risk
METHA-DROL Extreme capsules
Marketed without an Approved NDA/ANDA; product found to contain dimethazine which is a steroid and/or steroid-like drug ingredient, making it an unapproved new drug
Class I · High risk
Super-DMZ Rx 2.0 Capsules
Marketed without an Approved NDA/ANDA; product contains the steroid ingredient 2, 17a-dimethyl-17b-hydroxy-5a-androst-1-en-3-one, making it an unapproved new drug
Class I · High risk
B-50 capsules
Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug
Class I · High risk
Volcano Male Enhancement 1500mg
Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
Class I · High risk
Volcano Male Enhancement Liquid
Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
Class I · High risk
Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class I · High risk
Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class I · High risk
Esbelder Siloutte Suplemento Alimenticio
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class I · High risk
Esbelin Siloutte Te
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class I · High risk
Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio
Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.
Class I · High risk
0.75% Bupivacaine HCl Injection
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.