Elevated risk U.S. Food and Drug Administration

Neptune’s Fix Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir recall: Undeclared Tianeptine

Recall published 2+ years ago

Undeclared Tianeptine

Neptune’s Fix Prescription & OTC drugs — recalled prescription & otc drugsNeptune’s Fix Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Neptune’s Fix Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)
3 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

This is a labelling recall rather than a contamination one: something that must be declared is in the product and is not on the label.

What the notice says: Risk Statement: The FDA has advised that: There is a reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents, and young adults 25 and younger.

Why it matters: An ingredient that U.S. law requires to be declared is present but missing from the label. People who avoid that ingredient cannot make a safe choice from the packaging.

Symptoms and when to call a doctor

An undeclared allergen is a danger only to people allergic or intolerant to that ingredient. For everyone else the food is safe. Reactions range from an itchy mouth, hives, stomach cramps or vomiting through to anaphylaxis — swelling of the lips, tongue or throat, a tight chest, wheezing, a sudden drop in blood pressure or collapse. If anaphylaxis is suspected, use an epinephrine auto-injector straight away and call 911, even if the symptoms seem to settle, because a second wave can follow hours later.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
January 28, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Neptune’s Fix
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets

What the company announced

Neptune Resources, LLC Issues Voluntary Nationwide Recall of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets Products Due to the Presence of Tianeptine

KANSAS CITY, Mo., Jan. 28, 2024 /PRNewswire-PRWeb/ -- Neptune Resources, LLC is voluntarily recalling All lots of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets to the consumer level. Neptune Resources LLC's distribution channels have not reported any adverse events from the use of its products. The products are being recalled because they contain tianeptine, an ingredient that is not FDA-approved for any medical use. The presence of tianeptine renders the products unapproved drugs for which safety and efficacy have not been established and, therefore, are subject to recall.

Risk Statement: The FDA has advised that: There is a reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents, and young adults 25 and younger. In addition, individuals could unintentionally overdose and experience serious and potentially life-threatening risks including confusion, seizures, drowsiness, dry mouth, and shortness of breath, which may be exacerbated by alcohol use. Further, the risks of adverse effects associated with use of tianeptine along with antidepressants, known as monoamine oxidase inhibitors (MAOls), are potentially serious and life-threatening.

Neptune's Fix Elixir and Extra Strength Elixir are used as a supplement and are packaged in amber glass bottles with a "shrink sleeve" label that covers the entire cap/bottle and is perforated at the cap to facilitate opening. Neptune's Fix tablets are packaged in 20-count blister packs held in small boxes or 4-count foil packets. All Neptune's Fix products are being recalled. The product can be identified by the name Neptune's Fix and its logo which is an illustration of the Roman God Neptune with a green beard and a trident. The products were distributed Nationwide to wholesale and retail customers.

Neptune Resources is proactively notifying its distributors and customers by form of a mailed out recall letter and is arranging for the return of all recalled products.

Consumers/distributors/retailers that have product which is being recalled should stop using it and either destroy it or return it to place of purchase immediately.

Consumers with questions regarding this recall can contact Neptune Resources at 816-256- 2071, Monday-Friday 9am-6pm CT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

FDA Statement

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 20 count
  • 4 count

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Allergen

Neptune’s Fix — This is a labelling recall rather than a contamination one: something that must be declared is in the product and is not on the label.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Warn anyone else who eats from your kitchen, including schools and childminders.
  3. Report any reaction to the FDA so it is recorded against this recall.
  4. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Remedy named in the notice: Consumers/distributors/retailers that have product which is being recalled should stop using it and either destroy it or return it to place of purchase immediately.

Company contact: Neptune Resources, LLC — Consumers: Neptune Resources, 816-256- 2071 — Media: Neptune Resources, LLC, 1 (816) 256-2071

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Neptune’s Fix prescription & otc drugs recalled?

Undeclared Tianeptine Risk Statement: The FDA has advised that: There is a reasonable probability of life-threatening events including suicidal ideation or behavior for children, adolescents, and young adults 25 and younger.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.

Can I get my money back?

The notice says: Consumers/distributors/retailers that have product which is being recalled should stop using it and either destroy it or return it to place of purchase immediately.

Where was the recalled product sold?

It was distributed nationwide.

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