FDA Alert: Dietary supplement sold on Amazon recalled for containing prescription drug ingredients

Company Announcement

FOR IMMEDIATE RELEASE – 8/14/24 – Sacramento CA, Boulla LLC is voluntarily recalling lot number 230811, exp 8/11/25 of Boom Max capsules packaged in 10-count blisters packaged in a carton to the consumer level. Boulla LLC was notified by Amazon that the product was found to be tainted with sildenafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Products containing sildenafil cannot be marketed as dietary supplements. Boom Max is an unapproved new drug 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. To date, Boulla LLC has not received any reports of adverse events related to this recall.

The product was distributed via the internet and fulfilled by Amazon at www.amazon.com nationwide in the USA.

Boom Max is marketed as dietary supplements for male performance and energy and are packaged in 10-count blisters packaged in a Black and red carton, ASIN B0D2PRLQ79, Lot # 230811. The product can be identified by the label below.

Boulla LLC is notifying its distributors and customers by this press announcement and by Amazon Messaging and is arranging for return of all recalled products. Consumers that have Boom Max capsules lot number 230881 should stop using the product.

Consumers with questions regarding this recall can contact John Tran by phone number: 916- 619-7926 or e-mail at info at boullallc dot com Monday through Friday 9AM – 5PM PST. 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.

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
• Regular Mail or Fax: Download form 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 product lot recall is being made with the FDA’s knowledge.