FDA Recall D-0206-2024

Meta Herbal · East Hampton, NY

Class I — life-threatening Ongoing 897 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

Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ

Lot / code: All Lots

Quantity: 500 blister packs

Reason for recall

Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

Recall record

Recall number: D-0206-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: Nationwide in the USA. Product was sold via Amazon's Marketplace.
Recall initiated: 2023-11-29
Classified by FDA Center: 2023-12-27
FDA published: 2024-01-03
Recalling firm: Meta Herbal
Firm location: East Hampton, NY

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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