Neptune's Fix Products Recalled After FDA Warns Of Tianeptine Risk

(RTTNews) - Neptune Resources, LLC is recalling all lots of Neptune's Fix products after the U.S. Food and Drug Administration issued a warning against these products citing the presence of tianeptine, an ingredient that is not FDA-approved for any medical use.

In the US, tianeptine products are often marketed as dietary supplements that can improve brain function. The agency noted that tianeptine is a potentially dangerous substance that is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions.

The FDA had warned in November last year as well as last week against purchasing and using tianeptine products, including those sold under the name Neptune's Fix, after receiving severe adverse event reports, including seizures, loss of consciousness and death.

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.

These products may also interact with other medications a consumer may be taking.

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.

The recall involves all Neptune's Fix Elixir, Fix Extra Strength Elixir, and Fix Tablets to the consumer level. The products were distributed across the United States to wholesale and retail customers.

Neptune's Fix Elixir and Extra Strength Elixir are used as a supplement and are packaged in amber glass bottles, while Fix tablets are packaged in 20-count blister packs held in small boxes or 4-count foil packets.

Due to the presence of tianeptine, these products are unapproved drugs for which safety and efficacy have not been established and, therefore, are subject to recall.

However, Neptune Resources's distribution channels have not reported any adverse events from the use of its products to date.

The FDA sent a letter in early January to convenience store, gas station and other organizations urging retailers to stop selling Neptune's Fix and any other tianeptine-containing products.

Consumers, distributors and retailers are asked to stop using these products, and to either destroy them or return to place of purchase immediately.

The agency is investigating adverse event reports in conjunction with local and state health departments.

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