Safety Report: Magnum Male Sexual Enhancement capsule - recalled due to undeclared sildenafil, USA

United States

Meta Herbal is voluntarily recalling 500 blister packs of Magnum XXL 9800 2000 mg per capsule, to the consumer level. The products have been found to be tainted with Sildenafil. Products containing sildenafil cannot be marketed as dietary supplements. Magnum XXL 9800 capsules is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall. The product was distributed and sold online on Amazon under the ASINs: B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ. To date, Meta Herbal has not received any reports of adverse events related to this recall.

Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA-approved products for the treatment of male erectile dysfunction.

Risk Statement: Consumption of products with undeclared sildenafil 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.

The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister packs of one pill, with a UPC 645759993007 exp 1/2025. Each blister pack is sold individually and holds one capsule.

Meta Herbal is notifying its customers via Amazon and is arranging for refunds. All blister packs of Magnum XXL 9800 are affected by this recall. Consumers who have the recalled product should stop using it and contact Meta Herbal for return/refund instructions.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Meta Herbal
Brand name: Magnum
Product recalled: Magnum Male Sexual Enhancement XXL 9800 capsule
Reason of the recall: Undeclared Sildenafil
FDA Recall date: November 29, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/meta-herbal-issues-voluntary-nationwide-recall-magnum-xxl-9800-capsules-due-presence-undeclared