Neptune Resources LLC, the maker of Neptune’s Fix products, has issued a voluntary nationwide recall of all Neptune’s Fix products—Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir and Neptune’s Fix Tablets.

The move comes after the FDA issued a warning earlier in January that Neptune’s Fix had been the subject of multiple reports of serious medical injuries, including death. Neptune’s Fix products are labeled to contain the dangerous and addictive ingredient tianeptine, which is not approved for any medical use in the United States, said the FDA.

The FDA 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. 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. 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.”

FDA is investigating new Neptune’s Fix reports in conjunction with state and local partners. The agency has warned consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks.

To-date, 11 states have designated tianeptine as a controlled substance (i.e., Schedule I or Schedule II): Alabama, Florida, Georgia, Indiana, Kentucky, Michigan, Minnesota, Mississippi, Ohio, Oklahoma and Tennessee.

Consumers and retailers should report adverse events or side effects related to the use of Neptune’s Fix and similar products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online at MedWatch Online Voluntary Reporting Form, or;
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.