FDA (Drugs) recall action 93808
The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Neptune's Fix Tianeptine Elixir is recalled nationwide for containing tianeptine, an FDA-unapproved substance. The product was marketed without required FDA approval.
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.
Neptune's Fix Tianeptine Elixir has been recalled because it contains tianeptine, an unapproved drug substance in the United States. Approximately 1 million bottles distributed nationwide are affected.