Class I · High risk
vitaliKOR Ready When You Are
Marketed Without an Approved NDA/ANDA: FDA sampling found undeclared vardenafil and tadalafil in vitaliKOR capsules
FDA Drug Recalls
14,806 recalls, newest first
Class I · High risk
NATURECT Capsules Dietary Supplement 500 mg
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
Class I · High risk
P-BOOST Capsules Dietary Supplement 500 mg
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs.
Class I · High risk
RezzRX capsules
Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.
Class I · High risk
Clinimix 5/15 sulfite-free
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Class I · High risk
Clinimix E 4.25/10 sulfite-free
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Class I · High risk
Clinimix 4.25/25 sulfite-free
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Class I · High risk
50 mg Nitroglycerin in 5% Dextrose Injection
Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.
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
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
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
Class III · Low risk
Ketoconazole Cream
Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.
Class II · Moderate risk
Phenylephrine Nasal 1% Spray
Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablet
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Class III · Low risk
Fluconazole Oral Suspension
Failed Stability Specifications: this product is below specification for preservative content.
Class I · High risk
Glycopyrrolate
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class II · Moderate risk
10%, Travasol
Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured
Class II · Moderate risk
Valacyclovir Hydrochloride Tablets
Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets.
Class III · Low risk
Paclitaxel Injection
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Class I · High risk
Adipotrim XT
Marketed Without an Approved NDA/ANDA: FDA lab results found undeclared API Fluoxetine in this dietary supplement.
Class II · Moderate risk
Sumatriptan Succinate Injection
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.