FDA Recall D-0344-2024

Today The World · Portland, OR

Class I — life-threatening Ongoing 828 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683

Lot / code: Lot #: 2108, Exp. Date 10/31/2024.

Quantity: 11500 boxes

Reason for recall

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.

Recall record

Recall number: D-0344-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Product distributed nationwide within the United States.
Recall initiated: 2024-02-06
Classified by FDA Center: 2024-02-22
FDA published: 2024-02-28
Recalling firm: Today The World
Firm location: Portland, OR

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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