Neptune's Fix Tianeptine Tablets Recalled for FDA Unapproved Marketing
Neptune's Fix Tianeptine Tablets are being recalled because the product contains tianeptine, a substance not approved by the FDA for any medical use. The recall affects 4,932 boxes distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall. Regulatory guidance specifies Class I recalls must score no lower than 4 (Severe). No deaths or reported illnesses are documented in the source.
Plain-English summary
Neptune's Fix Tianeptine Tablets Extended Relief are being recalled nationwide. The product is manufactured and distributed by Neptune Resources, LLC, located at 30 N. Gould Street, Suite R, Sheridan, Wyoming 82801. A total of 4,932 boxes were distributed, with each box containing 20 tablets at 150 mg per tablet.
The product contains tianeptine, a substance that has not been approved by the U.S. Food and Drug Administration (FDA) for any medical use in the United States. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), which are required for drugs to be legally marketed in the country. All lot numbers of this product are included in the recall.
The recalled product
- Product
- 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.
- Manufacturer
- Neptune Resources, LLC
- Category
- Drug
- Hazard
- unapproved-substance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
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