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Recall Issued For Supplement Due To Presence Of Undeclared Ingredient

The recalled product
The recalled product Photo Credit: FDA/Distributor RFR, LLC

A company recalled a supplement that was sold across the United States due to the presence of an undeclared ingredient. 

Distributor RFR LLC recalled SANGTER Energy Supplements 3000mg with expiration date 01/2025 after Food & Drug Administration analysis found the products contained undeclared sildenafil, a substance found in FDA-approved treatments of male erectile dysfunction, according to an FDA announcement on Tuesday, Aug. 2.

The presence of sildenafil makes the supplements an unapproved new drug, the FDA reported. 

Undeclared sildenafil can interact with nitrates found in certain prescription drugs and cause a life-threatening drop in blood pressure, the FDA said. 

The product is marketed as a dietary supplement for male sexual enhancement and is packaged in a seven-count pack within a carton. 

The products were described through retail stores in Florida and nationwide across the United States online here.

Adverse reactions can be reported to the FDA's MedWatch Adverse Event Reporting program. Find out how to report adverse reactions here.

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