FDA Announces New Supplement Recall

By Policy and Advocacy Brief posted 09-19-2018 12:35


The Food and Drug Administration (FDA) is advising consumers not to purchase several nutritional supplements sold for sexual enhancement because an FDA laboratory analysis confirmed they contain the hidden ingredient sildenafil, an active ingredient in FDA-approved prescription drugs used to treat erectile dysfunction. The supplements include:

While there are no reports of illness associated with the supplements, they could pose a threat to consumers because the undeclared product can interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, and heart disease often take nitrates.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these products. Consumers can report adverse reactions or quality control problems to the FDA’s MedWatch Adverse Event Reporting program as follows:

  • Complete and submit reporting form online; or
  • Mail or fax reporting form. Download form or call 1-800-332-1088 to request a reporting form. Complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-1078.

The AUA strives to notify its members about pertinent FDA alerts and recalls including medical devices, drugs and supplements.  For previous notices, see prior issues of the Policy and Advocacy Brief.