FDA Recalls Neptune's Fix Tianeptine Elixir for Containing Unapproved Drug
Neptune's Fix Tianeptine Elixir has been recalled because it contains tianeptine, an unapproved drug substance in the United States. Approximately 1 million bottles distributed nationwide are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall of an unapproved drug product. Tianeptine is not FDA-approved for any medical use in the United States, and the agency's Class I classification requires a minimum severity score of 4.
Plain-English summary
Neptune Resources, LLC is recalling Neptune's Fix Tianeptine Elixir, a 10 mL liquid product distributed nationwide.
The product contains tianeptine, a substance that has not been approved by the FDA for medical use in the United States. The product was marketed without the required FDA approval (NDA or ANDA).
Approximately 1 million bottles were distributed nationwide in the USA. All lot numbers are included in this recall.
Consumers who have this product should stop using it and contact Neptune Resources, LLC with questions.
The recalled product
- Product
- Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
- Manufacturer
- Neptune Resources, LLC
- Category
- Drug — Unapproved Drug
- Hazard
- unapproved-drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
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