Neptune's Fix recall
FDA recall D-0334-2024 · initiated Jan 12, 2024
Neptune Resources, LLC recalled Neptune's Fix in Jan 2024 — an FDA Class I recall (D-0334-2024) because Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Sold unapproved, or found to contain something undeclared
The product should not have been on sale in this form — often a supplement found to contain a hidden prescription drug.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 117,000 bottles
Details
- 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.
- Recalling company
- Neptune Resources, LLC
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jan 12, 2024
- FDA report date
- Feb 28, 2024
Frequently asked
- Was Neptune's Fix recalled?
- Neptune Resources, LLC recalled Neptune's Fix in Jan 2024 — an FDA Class I recall (D-0334-2024) because Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Neptune's Fix recalled?
- Per the FDA enforcement record, the reason for recall D-0334-2024 was: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
- Is a recalled Neptune's Fix dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Neptune's Fix are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — All lots. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0334-2024.