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The United States: Primal Herbs issues voluntary nationwide recall of Primal Herbs Volume due to undeclared sildenafil (English only)
 
The United States Food and Drug Administration (FDA) announces that Primal Supplements Group LLC is voluntarily 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 healthcare 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.

Customers who placed an order between July 2, 2025 and September 19, 2025, on the website: primalherbs.com, should discontinue use immediately. The product is packaged in 8.5 oz round containers with green labels.

Please refer to the following website in FDA for details: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/primal-herbs-issues-voluntary-nationwide-recall-primal-herbs-volume-due-undeclared-sildenafil

In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 19 Sep 2025.

Ends/Thursday, Mar 12, 2026
Issued at HKT 14:30

 
 
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