Boulla LLC Initiates Nationwide Recall of ZoomMax and ZapMax Capsules Over Undisclosed Sildenafil and Diclofenac Contamination
Overview
- Announcement Date:
- FDA Publication Date:
- Product Classification:
- Dietary Supplements
Drugs - Reason for the Recall:
-
Recall Reason Description
Undeclared Sildenafil and Diclofenac
- Company Name:
- Boulla LLC
- Brand Name:
-
Brand Name(s)
Boulla LLC
- Product Information:
-
Product Description
Marketed as Dietary Supplement
Recall Announcement
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. Testing by the FDA revealed contamination with sildenafil, which is used in FDA approved medications for male erectile dysfunction, and diclofenac, a nonsteroidal anti-inflammatory drug (NSAID). These products cannot be marketed as dietary supplements and are categorized as unapproved new drugs lacking established safety and efficacy.
Consuming products that contain undeclared sildenafil may lead to serious interactions with nitrates present in certain prescription medications (e.g., nitroglycerin), resulting in potentially dangerous drops in blood pressure. Individuals with conditions such as diabetes, high blood pressure, high cholesterol, or heart disease are particularly at risk.
Undeclared diclofenac may elevate the chances of cardiovascular events such as heart attacks and strokes, in addition to serious gastrointestinal harm, including bleeding and perforation. This undeclared substance can also pose heightened risks, especially when consumers use other NSAID-containing products concurrently.
No adverse event reports connected to this recall have been received by Boulla LLC thus far.
The products were made available for purchase through Amazon.com in the USA.
ZoomMax and ZapMax capsules, which are marketed for male performance and energy, are packaged in 10-count blister packs within (ZoomMax – Orange and White Carton) and (ZapMax – Purple and White carton), identifiable with Lot#: YZM240406. The product labels are available for viewing below.
Boulla LLC is informing its distributors and customers through this press release and is facilitating the return of the recalled items via the Amazon return product option. Consumers in possession of ZoomMax or ZapMax capsules with lot number YZM240406 should cease usage immediately and contact their healthcare provider if they have encountered any issues related to these products.
For inquiries about this recall, consumers can reach Boulla LLC at boullallc@proton.me, Monday to Friday between 9 AM and 5 PM PST.
Any adverse reactions or quality issues with the use of this product can be reported to the FDA’s MedWatch Adverse Event Reporting System, which is available online, through regular mail, or by fax.
This recall is being conducted with the awareness of the U.S. Food and Drug Administration.