Safety Report: Neptune’s Fix, Fix Elixir, Fix Extra Strength Elixir & Fix Tablets - recalled due to undeclared tianeptine, USA

United States

Neptune Resources, LLC issues a voluntary recall of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets Products Due to the Presence of Tianeptine. The products were distributed nationwide in the USA to wholesale and retail customers. Neptune Resources LLC's distribution channels have not reported any adverse events from the use of its products.

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.

Neptune's Fix Elixir and Extra Strength Elixir are used as a supplement and are packaged in amber glass bottles with a "shrink sleeve" label that covers the entire cap/bottle and is perforated at the cap to facilitate opening. Neptune's Fix tablets are packaged in 20-count blister packs held in small boxes or 4-count foil packets. All Neptune's Fix products are being recalled. The product can be identified by the name Neptune's Fix and its logo which is an illustration of the Roman God Neptune with a green beard and a trident.

Neptune Resources is notifying its distributors and customers by form of a mailed out recall letter and is arranging for the return of all recalled products. Consumers/distributors/retailers that have product which is being recalled should stop using it and return it to place of purchase immediately.

In case you experience harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Neptune Resources, LLC
Brand name: Neptune’s Fix
Product recalled: Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets
Reason of the recall: Undeclared Tianeptine
FDA Recall date: January 29, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/neptune-resources-llc-issues-voluntary-nationwide-recall-neptunes-fix