(WKBN) — The U.S. Food and Drug Administration has announced the recall of pills that are used for male sexual enhancement.
According to the FDA, Meta Herbal is voluntarily recalling 500 blister packs of Magnum XXL 9800 2000 mg per capsule.
The FDA says the product, which is meant to be a dietary supplement, has been tainted with sildenafil, an ingredient known as a phosphodiesterase inhibitor (PDE-5), which is found in FDA-approved products used to treat erectile dysfunction.
Products with sildenafil as an ingredient cannot be sold as dietary supplements, the FDA says.
“Magnum XXL 9800 capsules is an unapproved new drug for which safety and efficacy has not been established and, therefore, subject to recall,” the FDA stated, adding that all blister packs of the affected capsules are subject to the recall.
The FDA said undeclared sildenafil, when ingested, could interact with nitrates found in some prescription medicines (such as nitroglycerin) and could cause blood pressure to drop significantly enough to be life-threatening.
“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 FDA said.
So far, there have been no reports of “adverse events” related to the affected product.
The FDA said the recalled product is packaged in blister packs of one pill with a UPC 6 45759 99300 7 (expiration January 2025). They were distributed and sold on Amazon under the identification numbers B07P7ZH797, B07P94J3ZT, B07P6VK6N3, and B076HNPZZZ.
Consumers are advised to stop using the capsules and contact Meta Herbal for return and refund instructions. The company is notifying customers through Amazon.
Consumers who experience problems that may be related to this product should contact their healthcare provider.
Questions can be emailed to Meta Herbal [email protected].
To report negative reactions or quality problems with this product, consumers can contact FDA’s MedWatch Adverse Event Reporting program online, by regular mail or by fax (1-800-FDA-0178).
Consumers can download a form or call 1- 800-332-1088 to request a reporting form.