Medical Toxicology
Image of dietary supplement bottles labeled ZoomMax and ZapMax with a caution symbol, indicating an FDA recall due to undeclared drug ingredients. Background includes a clipboard with a recall notice and a subtle FDA logo watermark for added context

FDA recall: Hidden drug ingredients found in ZoomMax and ZapMax supplements

 

In a significant health alert, California-based supplement company Boulla LLC has issued a voluntary nationwide recall of its products ZoomMax and ZapMax capsules. This recall follows testing by the U.S. Food and Drug Administration (FDA), which revealed the presence of undeclared active ingredients—sildenafil and diclofenac.

These ingredients are not disclosed on the packaging, posing serious health risks, especially to individuals on certain prescription medications or pre-existing conditions. Sildenafil, commonly used to treat erectile dysfunction, can dangerously interact with nitrate-based drugs such as nitroglycerin, leading to potentially life-threatening drops in blood pressure. Adult males who use nitrate medications for heart conditions are at the highest risk. Diclofenac, an NSAID used to manage pain and inflammation, can increase the risk of severe cardiovascular events and gastrointestinal issues, such as bleeding and ulcers.

Affected Products:

  • Lot Number: YZM240406

  • Expiry Date: 04/05/27

  • Packaging: 10-count blister packs

FDA Recommendations:

The FDA strongly advises consumers who have purchased ZoomMax or ZapMax capsules to immediately cease use and consult their healthcare provider if they have experienced any adverse reactions.

Company Actions:

Boulla LLC is coordinating the return of these products through its online platform, including Amazon.com, and has notified distributors and customers.

Reporting Adverse Effects: Adverse reactions or quality concerns can be reported to the FDA’s MedWatch Adverse Event Reporting Program online at www.fda.gov/medwatch/report.htm.

This recall underscores the importance of regulatory vigilance and consumer awareness regarding dietary supplements. Always exercise caution and consult with healthcare professionals before taking new supplements, especially when combined with prescription medications.

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