Distributor Recalls Products for Potentially Dangerous Ingredient

Super Chill Products is recalling all lots of Neptune’s Fix Tianeptine Elixir, according to the March 27, 2024, US Food and Drug Administration (FDA) Enforcement Report. The recall joins another issued earlier this year by Neptune Resources, Sheridan, Wyoming, for the entire line of Neptune’s Fix products. 

The FDA has designated all recalls for Neptune’s Fix products Class I because they contain tianeptine, an ingredient that is not approved for any medical use in the United States. A Class I designation warns use of the products could cause serious adverse health consequences or death.

The “FDA continues to receive severe adverse event reports after use of Neptune‘s Fix products, including seizures, loss of consciousness, and death,” the agency said in a January 23, 2024, update. “These products may also interact, in life-threatening ways, with other medications a consumer may be taking. The agency is actively investigating adverse event reports in conjunction with local and state health departments.”

The Super Chill Products’ recall affects 3573 bottles of Neptune’s Fix Tianeptine Elixir in 0.338-fluid-ounce (10-mL) bottles in cherry, lemon, and chocolate vanilla flavors. Super Chill Products, New York, New York, distributed the product throughout the United States.

The labels and packaging of Neptune’s Fix Tianeptine Elixir distributed by Super Chill Products may slightly differ from products distributed by Neptune Resources, according to the FDA. 

Super Chill Products voluntarily initiated the recall on February 5, 2024. The FDA issued the Class I designation on March 21, 2024.

“Consumers should not purchase or use any Neptune’s Fix products, or any other product with tianeptine — a potentially dangerous substance that is not FDA-approved for any medical use,” the FDA advised.