“These products may interact, in life-threatening ways, with other medications a consumer may be taking. We are actively investigating adverse event reports in conjunction with local and state health departments,” the FDA said in a Facebook post on Wednesday.
Neptune Resources, LLC has agreed to voluntarily recall all lots of this product at the consumer level, the FDA said.
“Consumers, distributors and retailers that have these products should either dispose of them or return them to place of purchase immediately.”
The product is mostly sold in convenience stores, gas stations and at other retailers.
“FDA is warning consumers not to purchase or use any Neptune’s Fix products, or any other product with tianeptine — a potentially dangerous substance that is not FDA-approved for any medical use but is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions,” states the FDA announcement on its website.
People having adverse reactions are reporting seizures and loss of consciousness leading to hospitalization.
“Neptune’s Fix labels state the product contains tianeptine, but the product may contain other harmful ingredients not listed on the label. These products, like other tianeptine products, can be purchased online and at gas stations, vape or smoke shops, or other locations. FDA is testing these products and will provide more information as it becomes available. FDA also continues to warn consumers about risks of using tianeptine,” states the FDA.
The FDA has sent a letter to retailers urging the removal of the products from shelves.
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