Neptune’s Fix Dietary Supplements are being recalled because they contain Tianeptine, which is not FDA-approved for any medical use. The presence of this ingredient makes the products unapproved drugs for which safety and efficacy have not been established. Life-threatening side effects can occur. No adverse events have been reported to the company to date. The recalling firm is Neptune’s Resources, LLC of Kansas City, Missouri.
Risk statement: The FDA has advised that there is a reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents, and young adults 25 and younger with the consumption of these products. 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. And 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 recalled products include Neptune’s Fix Elixir, Extra Strength Elixir, and Tablets. The elixirs are used as a supplement and are packaged in amber glass bottles with a shrink sleeve label that covers the entire cap and bottle and is perforated at the top to make opening easier. The tablets are packaged in a 20 count blister pack held in small boxes or four count foil packets. The products can be identified by the name and logo, which is an illustration of the Roman god Neptune. They were sold nationwide to wholesaler and retail customers.
If you bought any of these items, stop using them immediately. You can throw them away in a secure trash can, or take them back to the place of purchase for a refund.
If you or anyone you know have experienced adverse effects, see your doctor. You can report the incident to the FDA using the FDA’s MedWatch Adverse Event Reporting System.
