Recall - Gold Lion, ilum (Chocolate) produced by Gear Isle - Product contains sildenafil and tadalafil

Summary

Company Announcement

FOR IMMEDIATE RELEASE - March 19, 2026- West Sacramento, CA, Gear Isle is voluntarily recalling the following products to the consumer level. The products have been found to contain undeclared active pharmaceutical ingredients, sildenafil and tadalafil.

Gold Lion Aphrodisiac Chocolate Sachet, UPC 795847916279, LOT# no lot number, Expires: 06/2027 ilum Sex Chocolate, UPC 1002448578911, LOT# no lot number, Expires: 12/25/2027.

Risk Statement: Use of products with undeclared active ingredients sildenafil and tadalafil may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are most at risk from these products. To date, Gear Isle has not received any reports of adverse events related to this recall.

The product is labeled as a dietary supplement and is packaged as indicated in the table below. The product can also be identified by using the attached images. The products were distributed nationwide via internet sales.

Gear Isle is notifying its customers by notification letter and is arranging for returns and refunds of all recalled products. Consumers who have the product(s) (see table) that are being recalled should stop using them and return them for a refund.

Consumers with questions regarding this recall can contact Gear Isle customer service by calling 888-387-4753 or emailing [email protected] on Monday to Friday from 10 am to 4 pm PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm² or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.