Class I · High risk
Bella Vi BTrim MAX Dietary Supplement capsules
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Class I drug recalls - the high-risk category
Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious health consequences or death. It is a small share of all recalls, but the one to check first if a medication you take appears here.
1,750 recalls, newest first.
Class I · High risk
Bella Vi INSANE Bee Pollen Dietary Supplement Capsules
Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein
Class I · High risk
Slim Expert softgel capsules Dietary Supplement. One month…
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Class I · High risk
Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules.
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Class I · High risk
Slim Fortune capsules Dietary Supplement. Each bottle contains 30…
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
Class I · High risk
Virilis Pro
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Class I · High risk
PHUK Sexual Enhancement Ultimate Pleasure
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Class I · High risk
Prolifta Dietary Supplement Prolifta
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Class I · High risk
1% Lidocaine HCl Injection
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
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