Medications & Supplements/Dietary Supplements

Neptune's Fix Tianeptine Elixir Recalled for Unapproved Ingredient

Agency Publication Date: March 21, 2024

Summary

Super Chill Products is recalling 3,573 bottles of Neptune's Fix Tianeptine Elixir, Fast Acting, in 0.338 fl.oz. (10 mL) bottles. The product contains tianeptine, a chemical substance that is not FDA-approved for any medical use in the United States. This product was marketed and sold without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Risk

Tianeptine is an unapproved drug substance that poses serious health risks as its safety and effectiveness have not been established by the FDA. Consumers should not use products containing tianeptine as a treatment for any medical condition.

What You Should Do

This recall affects Neptune's Fix Tianeptine Elixir, Fast Acting, packaged in 0.338 fl.oz. (10 mL) bottles distributed by Super Chill Products of New York.
To identify the product, check the bottle label for 'Neptune's Fix Tianeptine Elixir' and the distributor address: 827 6th Avenue, New York, New York 10001. All lots that are currently within their expiration date are included in this recall.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Super Chill Products for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Neptune's Fix, Tianeptine Elixir, Fast Acting (0.338 fl.oz. / 10 mL)

Variants: 0.338 fl.oz., 10 mL

Lot Numbers:

All lots within expiry

Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001; Recall #: D-0393-2024

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93946

Status: Resolved

Manufacturer: Super Chill Products

Manufactured In: United States

Units Affected: 3,573 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Neptune's Fix Tianeptine Elixir, Fast Acting, packaged in 0.338 fl.oz. (10 mL) bottles distributed by Super Chill Products of New York.

To identify the product, check the bottle label for 'Neptune's Fix Tianeptine Elixir' and the distributor address: 827 6th Avenue, New York, New York 10001. All lots that are currently within their expiration date are included in this recall.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Super Chill Products for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.