Safety Report: Boulla ZoomMax and ZapMax Capsules - recalled due to Sildenafil and Diclofenac, USA

United States

Boulla LLC is voluntarily recalling ZoomMax and ZapMax Capsules to the consumer level. The products were found to be tainted with sildenafil and diclofenac. Products containing sildenafil and diclofenac cannot be marketed as dietary supplements. ZoomMax and ZapMax capsules are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall. The product was distributed via the internet on Amazon.com in the USA.

Sildenafil is an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors and Diclofenac is an FDA approved drug known as a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation.

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.

Use of products with undeclared diclofenac may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

The product recalled is ZoomMax and ZapMax Capsules with lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters in a cardboard carton.

Distributors and customers can return all recalled products by using the return product option on the Amazon platform. Consumers that have capsules should stop using the product.

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: Boulla LLC
Brand name: Boulla
Product recalled: ZoomMax Capsules and ZapMax Capsules
Reason of the recall: Undeclared Sildenafil and Diclofenac
FDA Recall date: November 05, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/boulla-llc-issues-voluntary-nationwide-recall-zoommax-and-zapmax-capsules-due-presence-undeclared