The FDA has announced a nationwide recall for ZoomMax and ZapMax capsules due to sildenafil and diclofenac undeclared ingredients. Boulla LLC is voluntarily recalling these capsules after testing revealed undeclared pharmaceutical ingredients that can pose severe health risks, especially for consumers taking specific medications. Sold on Amazon and marketed as dietary supplements, the capsules have been identified by lot number YZM240406 and should no longer be consumed. Want to learn more about what happened and how to protect yourself? Keep reading for all the details.
What happened?
Boulla LLC issued a voluntary recall of its ZoomMax and ZapMax capsules on November 4, 2024. FDA’s testing revealed that these supplements were tainted with sildenafil and diclofenac, two potent drugs that cannot legally be marketed as dietary supplements. ZoomMax and ZapMax capsules have not been approved by the FDA as safe or effective, therefore, they are subject to recall. They are marketed as dietary supplements intended to enhance male performance and boost energy, but they can’t be marketed this way due to the presence of Sildenafil and Diclofenac.
Product details:
Brand | Product | Size | Lot Number | Best By | Issue |
Boulla LLC | ZoomMaxCapsules | 10 count box | YZM240406 | 04/05/2027 | Undeclared Sildenafil and Diclofenac |
Boulla LLC | ZapMaxCapsules | 10 count box | YZM240406 | 04/05/2027 | Undeclared Sildenafil and Diclofenac |
What caused the issue?
Testing revealed that these products contained:
- Sildenafil: Commonly used to treat erectile dysfunction, it can dangerously lower blood pressure, especially for those on nitrate medications.
- Diclofenac: An NSAID that increases the risk of heart attack, stroke, and severe gastrointestinal issues.
- Groups at Risk: Adults with diabetes, high blood pressure, heart disease, or high cholesterol who may take nitrates.
- Symptoms: Dizziness, dangerously low blood pressure, cardiovascular issues, and gastrointestinal damage.
It is important to take into account that the consumption of products that contain undeclared sildenafil may interact with nitrates found in some prescription drugs such as (nitroglycerin). This can pose a severe health risk because it can cause a significant drop in blood pressure. Often, individuals with high blood pressure cholesterol, and heart disease take nitrates. Adult males who have heart conditions and use nitrates are the most at-risk group. The use of products with undeclared diclofenac may cause an increase in the risk of cardiovascular events such as heart attack or stroke. It can also cause severe gastrointestinal damage, including ulceration, bleeding, and perforation of the stomach and intestines. Relax! No adverse reactions have been reported to date.
Here’s what you should do
If you have ZoomMax or ZapMax capsules, take immediate action:
- Stop Using: Discontinue the use of the product immediately.
- Check Labels: Look for Lot#: YZM240406, expiring on 04/05/27.
- Contact Boulla LLC:
- Email: [email protected] (Monday-Friday, 9 AM–5 PM PST) for instructions on returns.
- Report Issues: Notify the FDA’s MedWatch Adverse Event Reporting program if you experience any side effects.
Behind the brand
Boulla LLC, based in Sacramento, CA, specializes in dietary supplements. While this is their first major recall, similar incidents in the industry highlight the importance of stringent testing. Recently, other recalls for undeclared ingredients have raised questions about supplement safety and transparency. For example, a July 2024 recall involved undeclared tadalafil in another dietary supplement, causing similar health risks. UMARY Hyaluronic Acid Tablets were also recalled due to the presence of hidden Diclofenac. Such trends emphasize the need for comprehensive quality control practices in the supplement industry since undeclared ingredients not only pose severe health risks but also harm consumer trust.
Ensuring safe eats
For consumers, always double-check product labels and rely on trusted suppliers. Have questions or need safe, reliable ingredient solutions? Contact our team at Source86 today and explore our curated range of products!
