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.
Reason for recall: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
Recall initiated: 20240112
Status: Ongoing
Classification: Class I
Recall type: Voluntary: Firm initiated