CLASS I ONGOING Drug recall · Reported 28 Feb 2024 · FDA Enforcement Report
Neptune's Fix, Tianeptine Tablets Extended Relief recalled
Neptune Resources is recalling Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per, Wide Awake, 3000 mg, distributed nationwide in the US. The recall was initiated on 12 Jan 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0335-2024
- FDA event ID
- 93808
- Recalling firm
- Neptune Resources, Kansas City, MO
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 12 Jan 2024
- FDA classified
- 16 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Hidden Drug Ingredients
Timeline
| 12 Jan 2024 | Recall initiated by company | |
| 16 Feb 2024 | Classified by FDA | +35 days |
| 28 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Which lots are affected?
All lots
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93808| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Neptune's Fix, Tianeptine Extra Strength Elixir recalled | Neptune Resources | Hidden Drug Ingredients | Nationwide | |
| CLASS I | Neptune's Fix, Tianeptine Elixir, Fast Acting recalled | Neptune Resources | Hidden Drug Ingredients | Nationwide |
More recalls from Neptune Resources
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Neptune's Fix, Tianeptine Elixir, Fast Acting recalled | Neptune Resources | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS I | Neptune's Fix, Tianeptine Extra Strength Elixir recalled | Neptune Resources | Hidden Drug Ingredients | Nationwide |