Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

112 recalls · Class I, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2013 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

eXtenZone capsules

Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone 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 b

Terminated Chemical / undeclared SS Wholesale Inc. dba Jobbers Wholesale D-1047-2014
Class I · High risk

MaXtremeZEN capsules

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

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

Rhino 5 capsules

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

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

Glycopyrrolate

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

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

Adipotrim XT

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

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

Hydravax High Potency Diuretic Weight Loss Solution

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

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

Soliris (eculizumab)

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

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

Human Chorionic Gonadotropin

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

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

Dextrose* Vial In Sterile Water

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

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

Marcaine (bupivacaine HCl)

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.

Terminated Particulate / foreign matter Hospira Inc. NDC 0409-1559-30 D-1161-2014
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.

Terminated Unapproved drug Haute Health, LLC D-1237-2014

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