SCHWINNNG Herbal Dietary Supplement recall
FDA recall D-0344-2024 · initiated Feb 6, 2024
Today The World recalled SCHWINNNG Herbal Dietary Supplement in Feb 2024 — an FDA Class I recall (D-0344-2024) because Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
Sold unapproved, or found to contain something undeclared
The product should not have been on sale in this form — often a supplement found to contain a hidden prescription drug.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 11500 boxes
Details
- Product
- SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683
- Recalling company
- Today The World
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Product distributed nationwide within the United States.
- Initiated
- Feb 6, 2024
- FDA report date
- Feb 28, 2024
Frequently asked
- Was SCHWINNNG Herbal Dietary Supplement recalled?
- Today The World recalled SCHWINNNG Herbal Dietary Supplement in Feb 2024 — an FDA Class I recall (D-0344-2024) because Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was SCHWINNNG Herbal Dietary Supplement recalled?
- Per the FDA enforcement record, the reason for recall D-0344-2024 was: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.
- Is a recalled SCHWINNNG Herbal Dietary Supplement dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of SCHWINNNG Herbal Dietary Supplement are affected?
- Distributed: Product distributed nationwide within the United States.. The recall covers these lots — Lot #: 2108, Exp. Date 10/31/2024.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0344-2024.