“Magnum XXL 9800” pills marketed as dietary supplements have been voluntarily recalled by Meta Herbal because they are tainted with sildenafil, according to the U.S. Food and Drug Administration.
“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,” said a recall notice published by the FDA. As of Nov. 28, Meta Herbal had not received any reports of adverse events related to Magnum XXL 9800 pills.
Adult males – the people most likely to use the recalled product – often take nitrates for cardiac conditions. People also take nitrates for diabetes, high blood pressure, high cholesterol, or heart disease.
Although sildenafil, a Phosphodiesterase Inhibitor (PDE-5), is found in FDA-approved products for the treatment of male erectile dysfunction, products that contain it cannot be marketed as dietary supplements. Per the FDA, the 200 mg Magnum XXL 9800 capsules are unapproved new drugs “for which safety and efficacy has not been established.”
These capsules were sold by the E. Hampton, N.Y., company in blister packs containing one pill via Amazon. They had a UPC of 6 45759 99300 7, expiration date of 1/2025 and the following ASINs: B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ.
“Meta Herbal is notifying its customers via Amazon and is arranging for refunds,” said the recall notice. “All blister packs of Magnum XXL 9800 are affected by this recall. Consumers that have the recalled product should stop using and contact Meta Herbal for return/refund instructions.”
Consumers who have questions regarding the recall can contact Meta Herbal at info@metaherbal.com. Anyone who has taken the pills and experienced problems should contact their physician or healthcare provider. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail or by fax.
To submit via regular mail or fax, consumers can download this form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.