US Drug Recall Register

FDA Drug Recalls

1,739 recalls · Class I, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 2026202520242023
Class I · High risk Terminated

MaXtremeZEN capsules

Reason Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved

SS Wholesale Inc. dba Jobbers Wholesale D-1046-2014
Class I · High risk Terminated

Rhino 5 capsules

Reason Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by

SS Wholesale Inc. dba Jobbers Wholesale D-1045-2014
Class I · High risk Terminated

Glycopyrrolate

Reason Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.

Brookfield Prescription Center Inc D-1252-2014
Class I · High risk Terminated

Adipotrim XT

Reason Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.

Deseo Rebajar D-1277-2014
Class I · High risk Terminated

Hydravax High Potency Diuretic Weight Loss Solution

Reason Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug

IQ Formulations, LLC D-1050-2014
Class I · High risk Terminated

Soliris

Reason Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.

Alexion Pharmaceuticals, Inc. NDC 25682-001-01 D-1049-2014
Class I · High risk Terminated

Human Chorionic Gonadotropin

Reason Labeling: Label Error on Declared Strength; Firm states that erroneous potency information was found on the label.

Medisca Inc. NDC 38779-2673-1 D-1263-2014
Class I · High risk Terminated

Dextrose* Vial In Sterile Water

Reason Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product.

Specialty Medicine Compounding Pharmacy, P.C. D-1156-2014
Class I · High risk Terminated

Marcaine

Reason Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.

Hospira Inc. NDC 0409-1559-30 D-1161-2014
Class I · High risk Terminated

Cefepime for Injection USP and Dextrose Injection USP

Reason Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.

B. Braun Medical Inc NDC 0264-3193-11 D-1054-2014
Class I · High risk Terminated

Bella Vi BTrim MAX Dietary Supplement capsules

Reason Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phenolphthalein

Pure Edge Nutrition D-1366-2014
Class I · High risk Terminated

Virilis Pro

Reason 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.

Haute Health, LLC D-1237-2014
Class I · High risk Terminated

PHUK Sexual Enhancement Ultimate Pleasure

Reason 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.

Haute Health, LLC D-1236-2014
Class I · High risk Terminated

Prolifta Dietary Supplement Prolifta

Reason 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.

Haute Health, LLC D-1235-2014
Class I · High risk Terminated

1% Lidocaine HCl Injection

Reason Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.

Hospira, Inc. NDC 0409-4276-01 D-1234-2014
Class I · High risk Terminated

Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution

Reason 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.

Altaire Pharmaceuticals, Inc. D-375-2014
Class I · High risk Terminated

Aminosyn II

Reason Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.

Hospira Inc. NDC 0409-4164-03 D-461-2014