According to the FDA, Neptune’s Fix Elixir, Neptune’s Fix Extra Strength Elixir, and Neptune’s Fix Tablets have all been recalled by Neptune Resources, LLC because the products contain tianeptine.
While the company has not received any reports of adverse events to date of the announcement, authorities say tianeptine has not been cleared by the FDA for any medical use. Any products containing tianeptine are therefore rendered unapproved drugs; the safety and efficacy of such drugs have therefore not been established, and faces recall.
In its risk statement, the FDA indicated that there is “a reasonable probability” that consuming tianeptine could lead to “life-threatening events including suicidal ideation or behavior” in certain groups, including “children, adolescents, and young adults 25 and younger.” The unauthorized product could also create conditions that cause individuals to unintentionally overdose or suffer other “life-threatening risks,” such as “confusion, seizures, drowsiness, dry mouth, and shortness of breath,” the risk of which could be increased when paired with use of alcohol. Officials also warned that the adverse effects of tianeptine use with antidepressants, or monoamine oxidase inhibitors (MAOIs), also poses a major and life-threatening risk to consumers.
Both Neptune’s Fix Elixir and Extra Strength Elixir are taken as a supplement and come in amber glass bottles wrapped in a “shrink sleeve” label that covers the entire finished product and is perforated at the cap area. Neptune’s Fix tablets are sold either as 20-count blister packs in small boxes, or as 4-count foil packets.
Consumers should note that all Neptune’s Fix products are covered by the nationwide recall. Products under the brand are distinguished by the prominently place “Neptune’s Fix” lettering and the brand logo, which features an image of Roman God Neptune, depicted with a green beard and holding a trident in hand. Photos of the affected products, in all of their available packaging styles, can be referenced in the FDA communication.
Initiated by the company on January 28, 2024, the nationwide recall covers all lots of the three products to the consumer level.
While no adverse events related to product use has been reported within the distribution channels of Neptune Resources LLC, the company alerted its distributors and customers of the problem via a mailed recall letter. At the time of the FDA announcement, it was also working to establish a return program for all of the recalled products.
Any consumer, distributor, or retail partner who may have the product in their possession is urged to discontinue use. The item(s) should either be safely discarded or taken back to the point of purchase as soon as possible.
Further questions can be directed to Neptune Resources at 816-256-2071 on Monday through Friday, from 9:00 a.m. to 6:00 p.m. Central Time. Anyone experiencing health problems believed to be linked to product use should contact their healthcare provider immediately.
As the FDA continues to oversee the recall, the agency encourages consumers to report any associated adverse reactions or quality issues to its MedWatch program.
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