Class I — Most Severe

Gear Isle Recalls Chocolate for Undeclared Sildenafil

FreshRecall Team Gear Isle Undeclared Drug

Class I Recall — Most Serious

This is a Class I recall — the most serious type. Products covered by this recall may cause serious health consequences or death.

Image of ilum sale sexual enhancement individual packet Image of labeling, Fantasty Aphrodisiac Chocolate

Gear Isle has issued a voluntary nationwide recall of two chocolate products due to the presence of undeclared active pharmaceutical ingredients, sildenafil and tadalafil. These ingredients can pose serious health risks, particularly for individuals taking nitrates for cardiac conditions, as they may cause a dangerous drop in blood pressure.

Affected Products:

  • Gold Lion Aphrodisiac Chocolate Sachet, UPC 795847916279, Expiration: 06/2027
  • ilum Sex Chocolate, UPC 1002448578911, Expiration: 12/25/2027

Both products are labeled as dietary supplements and were distributed nationwide through online sales. They do not have lot numbers.

Reason for Recall:

The recall was initiated because the chocolates contain undeclared sildenafil and tadalafil, which can interact with certain medications and pose a significant health risk.

Consumer Action:

Consumers are advised to stop using these products immediately and return them for a refund. Gear Isle is contacting customers directly and arranging returns. For questions, consumers can contact Gear Isle customer service at 888-387-4753 or [email protected], Monday to Friday, 10 am to 4 pm PST.

Health Risk Information:

While no adverse events have been reported to date, individuals experiencing any health issues related to these products should contact their healthcare provider. Adverse reactions can also be reported to the FDA's MedWatch program.

This recall is conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Affected Products

Product Name UPC Lot Number Expiration Date Package Size
Gold Lion Aphrodisiac Chocolate Male Enhancement Sachet 795847916279 No lot number 06/2027 1-count
ilum Sex Chocolate Male Sexual Enhancement Booster 1002448578911 No lot number 12/25/2027 1-count

Where Products Were Sold

This recall affects products distributed nationwide across the United States.

Tags

View original FDA announcement