Class I Recall for Elixirs, Tablets Featuring Unapproved Drug

A Class I recall has been issued for all Neptune’s Fix products because they contain tianeptine, an ingredient that is not approved for any medical use in the United States. 

“The presence of tianeptine renders the products unapproved drugs for which safety and efficacy have not been established and, therefore, are subject to recall,” recalling firm Neptune Resources, Kansas City, Missouri, stated in a January 28, 2024, company announcement. 

The US Food and Drug Administration (FDA) designated the recall Class I, according to the February 28, 2024, FDA Enforcement Report. The FDA’s most serious recall classification, a Class I designation warns used of the products could cause serious adverse health consequences or death. 

“There is a reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents, and young adults 25 and younger. In addition, individuals could unintentionally overdose and experience serious and potentially life-threatening risks including confusion, seizures, drowsiness, dry mouth, and shortness of breath, which may be exacerbated by alcohol use,” Neptune Resources stated.  

“Further, the risks of adverse effects associated with use of tianeptine along with antidepressants, known as monoamine oxidase inhibitors (MAOls), are potentially serious and life-threatening.” 

The recall includes all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets. Neptune Resources, Sheridan, Wyoming, distributed the products to wholesale and retail customers throughout the United States. A total 1 million bottles are affected. 

Neptune Resources voluntarily initiated the recall January 12, 2024. The FDA issued its Class I designation on February 16, 2024. 

Neptune’s Fix Elixir and Extra Strength Elixir are marketed as dietary supplements and are packaged in amber glass bottles with a shrink sleeve label that covers the cap and bottle. Neptune’s Fix tablets are packaged in 20-count blister packs and 4-count foil packets.