August 1, 2022 – Miami, Florida, DISTRIBUTOR RFR, LLC. is voluntarily recalling lot #48656, Exp. 01/2025 of SANGTER Energy Supplement, 3000 mg, packaged in 7-count blister packs within a carton to the consumer level. FDA analysis has found the product to contain undeclared sildenafil. Sildenafil is a phosphodiesterase (PDE-5) inhibitor found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil in SANGTER makes it an unapproved new drug for which the safety and efficacy has not been established and, therefore subject to recall.
Use of SANGTER with undeclared sildenafil may pose a threat to consumers because it 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 these products, adult males who use nitrates for cardiac conditions are at the most at risk from these products. To date, DISTRIBUTOR RFR, LLC. has not received any reports of adverse events related to this recall.FDA Alert: Distributor RFR, LLC, Voluntary Nationwide Recall of Sangter Energy Supplement Due to Presence of Undeclared Sildenafil