Neptune’s Fix Recall Issued After FDA Tianeptine Warning

The FDA has issued repeated warning about serious health risks from Neptune’s Fix and other dietary supplements containing tianeptine over the last two years.

Federal health officials have announced a Neptune’s Fix recall after discovering the supplements contain an unapproved antidepressant drug that can increase the risk of serious of serious side effects and potentially life threatening interactions with prescription medications.

The U.S. Food and Drug Administration (FDA) announced the Neptune’s Fix recall on January 29, following an investigation that determined many of the Neptune’s Fix products contain a medicine used to treat depression that can cause overdoses, seizures, loss of consciousness, and suicidal behavior.

Neptune’s Fix is marketed as a dietary supplement to improve brain function, anxiety, depression, pain, and opioid use disorders. However, the FDA is warning the products contain the drug tianeptine, often referred to as “gas station heroin,” which acts on opioid receptors and is prescribed as an antidepressant in some other countries, but has not been approved for medical use in the United States.

Neptune’s Fix Side Effect Warnings

The FDA initially warned about the risks of dietary supplements containing tianeptine in November 2018, stating exposure to tianeptine has been linked to a growing number of serious adverse events, and that consumers may inadvertently find themselves addicted to the drug, especially those recovering from opioid use disorder.

In February 2022, the FDA issued another tianeptine warning, advising consumers to avoid Coaxial, Stablon or Tianna supplements containing tianeptine that were being illegally marketed as a dietary supplement capable of  treating various ailments, which are not approved by the FDA.

Last week, the agency warned consumers about a link between Neptune’s Fix and seizures, loss of cosciousness and other life-threatening side effects reported by consumers.

Neptune’s Fix Recall

In November 2023, federal health officials initiated an investigation into Neptune’s Fix brand products after discovering the presence of tianeptine in their formulations. During the initial warning, the manufacturer indicated that while the use of tianeptine was listed on the label, other harmful ingredients not disclosed on the label were also present.

On January 28, the Neptune’s Fix recall was issued by the manufacturer, Neptune Resources, LLC, days after the latest FDA warning, impacting all lots of Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets.

Neptune’s Fix Elixir and Extra Strength Elixir are sold as dietary supplements and packaged in amber glass bottles with a “shrink-sleeved” label that covers the entire bottle and cap. The label is perforated at the cap for easy opening. Neptune’s Fix Tablets come in a 20-count blister pack contained within small boxes or 4-count foil packets. The product is identifiable by the Neptune’s Fix name or the logo featuring the Roman God Neptune with a green beard and trident.

The Neptune’s Fix products were distributed nationwide to wholesale and retail customers. Neptune’s Fix is notifying its distributors and customers by mail with the recall notice and providing further instructions. Consumers, distributors, and retailers who have been notified and possess the products should immediately stop use and either destroy the products or return them to the place of purchase promptly.

Tianeptine Overdose & Seizure Risks

The FDA is warning individuals with a history of opioid use disorder or dependence may face an increased risk of abusing tianeptine due to its addictive and euphoric effects. The misuse and abuse of this supplement can lead to severe side effects, such as confusion, rapid heartbeat, elevated blood pressure, nausea, slowed or stopped breathing, coma, and even death.

Additionally, the agency advised that there is a reasonable probability of life-threatening events, including suicidal ideation or behavior, for children, adolescents, and young adults aged 25 and younger. Further risk may include individuals unintentionally overdosing, experiencing confusion, seizures, drowsiness, dry mouth, and shortness of breath. The risks of tianeptine interacting with antidepressants can lead to adverse effects that are potentially serious and life-threatening.

Poison control centers have witnessed a significant surge in reported cases of tianeptine exposure, with the number of reactions skyrocketing from 11 cases between 2000 and 2013 to 151 cases in 2020 alone.

Consumers and healthcare professionals should report any adverse reactions or side effects related to the use of this products to the FDA’s MedWatch Adverse Event Reporting Program. For individuals experiencing side effects of Neptune’s Fix, the FDA directed consumers to contact Poison Help at 1-800-222-1222 to connect to their local poison control center. Consumers with questions regarding this recall can also contact Neptune Resources at 816-256-2071.