Drug Recalled for Marketing Unapproved Tianeptine Without FDA Approval
Neptune's Fix Tianeptine Elixir is recalled nationwide for containing tianeptine, an FDA-unapproved substance. The product was marketed without required FDA approval.
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 designation requires a minimum severity score of 4 (Severe) per the rubric. No reported illnesses or deaths are mentioned in the source.
Plain-English summary
Neptune's Fix Tianeptine Extra Strength Elixir, a 0.338 fl oz (10 mL) bottle product, is being recalled nationwide. The product is distributed by Neptune Resources, LLC, located at 30 N. Gould Street, Ste R, Sheridan, Wyoming 82801.
The recall was issued because the product contains tianeptine, a substance that has not been approved by the FDA for any medical use in the United States. The product was marketed and sold without the required FDA new drug application (NDA) or abbreviated NDA (ANDA) approval.
Approximately 117,000 bottles of this product were distributed across the United States. Consumers who have purchased Neptune's Fix Tianeptine Extra Strength Elixir should stop using it immediately and speak with their healthcare provider if they have concerns about their use of this product.
The recalled product
- Product
- Neptune's Fix, Tianeptine Extra Strength Elixir, 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
- Affected units
- 117,000
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.
Part of a larger recall action
This product is one of 3 recalled by Neptune Resources, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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