Elevated risk U.S. Food and Drug Administration

Sustain and Schwinnng brand male enhancement capsules recall: Products contain undeclared Tadalafil and Nortadalafil

Recall published 2+ years ago

Products contain undeclared Tadalafil and Nortadalafil

Sustain, Schwinnng Prescription & OTC drugs — recalled prescription & otc drugsSustain, Schwinnng Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Undeclared allergen or ingredient

An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

What the notice says: Risk Statement: Consumption of products with undeclared tadalafil or nortadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.

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
February 2, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Sustain, Schwinnng
Product type
Prescription & OTC drugs
Distribution
Nationwide
Sold at
Amazon
Reports of harm
To date, no adverse events have been reported.

Products covered by this recall

Sustain and Schwinnng brand male enhancement capsules

What the company announced

FOR IMMEDIATE RELEASE – February 2, 2024 - VANCOUVER, WA, “Today The World” is voluntarily recalling two lots of Sustain herbal dietary supplement capsules and one lot of Schwinnng capsules to the consumer level. FDA analysis has found the products to contain undeclared Tadalafil and Nortadalafil (structurally similar to Tadalafil). Tadalafil and Nortadalafil are active drug ingredients known for treatment of male erectile dysfunction. The presence of Tadalafil and Nortadalafil in Sustain capsules and Schwinnng capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Risk Statement: Consumption of products with undeclared tadalafil or nortadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk. To date, no adverse events have been reported.

These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged and coded as follows:

SUSTAIN: BTH:230551, EXP:12.05.2026, BTH: 230571, EXP: 14.05.2026

SCHWINNNG Lot 2108 EXP 10/2024

Products were distributed via Amazon at www.amazon.com and www.sustainformula.com and www.schwinnng.com.nationwide in the USA.

Today The World is notifying its customers by this press announcement of this recall release and is arranging for return/replacement etc. of all recalled products. Consumers that have Sustain or Schwinnng which is being recalled should stop using and destroy them/return if desired to Today The World, 11954 NE Glisan St # 405 Portland OR 97220. The Sustain and Schwinnng products must include the blister pack foil (with any pills remaining) containing all lot codes and receipt of proof of purchase, and your return address.

Consumers with questions regarding this recall can contact Today The World by e-mail [email protected] and [email protected] or customers can call 888-767-4889 or text 360-747-7411, between the hours of 10 a.m. and 5 p.m. Pacific Standard Time Monday-Friday, for instructions on the return and refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Today The World. is committed to improving its products and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing. Today The World. promises its customers the highest possible quality and welcomes the recall process as further evidence of our commitment to our brands, products and consumers.

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

Regular Mail or Fax: Download form 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.

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

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 2108

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 12.05.2026
  • 14.05.2026
  • 10/2024

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

Sustain, Schwinnng — An ingredient subject to mandatory disclosure was left off the packaging, which is what the agency classes as misbranding.

  1. Read the official notice above for the exact ingredient involved, then check whether anyone in your home avoids it.
  2. Report any reaction to the FDA so it is recorded against this recall.
  3. If nobody here avoids it, the product is safe to eat; the refund is still available if you would rather return it.
  4. If someone does avoid it, stop serving it and check anything already cooked with it.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Remedy named in the notice: Today The World is notifying its customers by this press announcement of this recall release and is arranging for return/replacement etc. of all recalled products.

Company contact: Today the World — Consumers: 888-767-4889 or text 360-747-7411, between the hours of 10 a.m. and 5 p.m. Pacific Standard Time Monday-Friday, [email protected], [email protected]

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 Sustain, Schwinnng prescription & otc drugs recalled?

Products contain undeclared Tadalafil and Nortadalafil Risk Statement: Consumption of products with undeclared tadalafil or nortadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 2108; best-by date 12.05.2026 or 14.05.2026. If the code on your package is not on that list, your unit is outside the recall.

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: Today The World is notifying its customers by this press announcement of this recall release and is arranging for return/replacement etc. of all recalled products.

Where was the recalled product sold?

It was distributed nationwide, including at Amazon.

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