|
If your email program has trouble displaying this email, view as a webpage.
|
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
|
 
TOPIC: Primal Herbs Volume by Primal Herbs: Recall - Due to Undeclared Sildenafil
AUDIENCE: Consumer, Health Care Professional, Pharmacy, Cardiology
ISSUE: Primal Supplements Group is recalling all orders of Primal Herbs Volume placed between July 2 and September 19, 2025, because FDA laboratory analysis confirmed that Primal Herbs Volume contains sildenafil not listed on the product label.
Sildenafil is the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction. FDA approval of Viagra is restricted to use under the supervision of a licensed health care professional. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is sold as dietary supplement.
RECOMMENDATIONS:
-
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
-
Consumers who placed an order between July 2, 2025, and September 19, 2025, on the website: primalherbs.com should discontinue use immediately. If an order was placed during this timeframe, please stop using the product and contact team at hello@primalherbs.com with the order number.
-
For questions or concerns, please contact hello@primalherbs.com or +1 (856) 420-6117.
|
