The Food and Drug Administration announced on Jan. 12, 2024, that Neptune Resources, LLC is recalling Neptune's Fix Tianeptine Tablets Extended Relief because the product contains tianeptine, a substance not approved for medical use in the United States. The company initiated this voluntary Class I recall nationwide.
How to tell if you have it
- Brand: Neptune's Fix
- Product: Tianeptine Tablets Extended Relief
- Quantity: Twenty Tablets per Box
- Strength: Wide Awake, 3000 mg (150 mg Per Tablet)
- Distributor: Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801
- Units affected: 4,932 boxes
The hazard
According to the FDA, the product is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The hazard stems from the presence of tianeptine, which is not approved for any medical use in the United States.
Context
GovInfoNow's records show other recent recalls of similar products include SUN PHARMACEUTICAL Xyvona 3mg Tablets Recall (2026-05-22) and Xyvona (Levorphanol) 2mg Tablet Recall (2026-05-22), both involving FDA denial of marketing. Additionally, Buy-Herbal Kian Pee Wan Capsules Recall occurred on 2026-03-21 due to undeclared drug ingredients.