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Stop using now Drug recall · FDA · Published January 12, 2024

Neptune's Fix Tianeptine Recall: Unapproved Drug Hazard

Neptune Resources recalls Neptune's Fix tianeptine tablets because they are marketed without FDA approval. Check if you have the affected product.

🇺🇸 FDA recall #D-0335-2024DrugNeptune's Fix ›
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Recalling firmNeptune Resources, LLC1324 W 12th St Fl 5 · Kansas City, MO 64101-1343
✎ GovInfoNow plain-language explainer

Neptune Resources, LLC is recalling Neptune's Fix Tianeptine Tablets Extended Relief because the product contains tianeptine, a substance not approved by the FDA for any medical use in the United States. The company distributed 4,932 boxes nationwide. Because the drug lacks regulatory approval, its safety and efficacy have not been verified. Read more at govinfonow.com/recall/32880-neptune-s-fix-tianeptine-recall-unapproved-drug-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/32880-neptune-s-fix-tianeptine-recall-unapproved-drug-hazard · Updated October 9, 2026 · FDA enforcement record: FDA #D-0335-2024

Cite this page

“Neptune's Fix Tianeptine Recall: Unapproved Drug Hazard.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32880-neptune-s-fix-tianeptine-recall-unapproved-drug-hazard. Based on FDA recall #D-0335-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0335-2024%22&limit=1).

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.

How to tell if you have this one

Look for boxes labeled "Neptune's Fix, Tianeptine Tablets Extended Relief" containing twenty tablets per box, with a strength of 3000 mg (150 mg per tablet). The product was distributed by Neptune Resources, LLC, located at 30 N. Gould Street, Ste R, Sheridan, WY 82801. All lots are included in this recall.

  • Brand
    Neptune's Fix
  • Category
    Drug
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    Nationwide in the USA
Recall numberProduct, codes & lotsQuantity
D-0333-2024Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.; All lots1,000,000 bottles
D-0334-2024Neptune'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.; All lots117,000 bottles
D-0335-2024Neptune'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.; All lots4,932 boxes
Based on the official FDA remedy

What to do — step by step

  1. Stop Using the Product

    Do not consume any of the recalled Neptune's Fix Tianeptine Tablets.

  2. Discard or Return Items

    Dispose of the product safely or return it to the place of purchase, as no specific manufacturer remedy is listed in the record.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 47 days after the firm started it.

1. Firm started the recall: Jan 12, 202412. FDA classified it Class I: Feb 16, 202423. Published in FDA’s Enforcement Report: Feb 28, 202432024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0335-2024 (January 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0335-2024 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA