What happened
Original notice title
Neptune Resources, LLC Issues Voluntary Nationwide Recall of Neptune’s Fix
From the archived source record
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. More Recalls, Market Withdrawals, & Safety Alerts Recalls, Market Withdrawals, & Safety Alerts Recall Resources Enforcement Reports Industry Guidance For Recalls Major Product Recalls Neptune Resources, LLC Issues Voluntary Nationwide Recall of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets Products Due to the Presence of Tianeptine KANSAS CITY, Mo., Jan. 28, 2024 /PRNewswire-PRWeb/ -- Neptune Resources, LLC is voluntarily recalling All lots of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets to the consumer level. Neptune Resources LLC's distribution channels have not reported any adverse events from the use of its products. The products are being recalled because they contain tianeptine, an ingredient that is not FDA-approved for any medical use. The presence of tianeptine renders the products unapproved drugs for which safety and efficacy have not been established and, therefore, are subject to recall. 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. 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.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Published recall notice
- Source checked
- Jul 16, 2026
- Record revision
- 6fada6f43d70
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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