Boulla Marketed as Dietary Supplement recall: Undeclared Sildenafil and Diclofenac

What the company announced

FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. The products were found to be tainted with sildenafil via testing by the FDA, 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, an FDA approved drug known as a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. 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.

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, including bleeding, ulceration, and fatal perforation of the stomach and intestines. 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.

To date, Boulla LLC has not received any reports of adverse events related to this recall.

The product was distributed via the internet on Amazon.com in the USA.

ZoomMax capsules and ZapMax capsules are marketed as dietary supplements for male performance and energy and are packaged in 10-count blisters packaged in an (ZoomMax - Orange and White Carton) and (ZapMax in Purple and White carton) with Lot#: YZM240406. The products can be identified by the labels below.

Boulla LLC is notifying its distributors and customers by this press announcement and is arranging for return of all recalled products by using the return product option on the Amazon platform. Consumers that have ZoomMax or ZapMax capsules lot number YZM240406 should stop using the product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers with questions regarding this recall can contact Boulla LLC via e-mail at [email protected] Monday through Friday 9AM – 5PM PST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

VitalityVita Press Release

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.