Distributor RFR, LLC. has issued a voluntary nationwide recall of Sangter Energy Supplement. The product has lot #48656, Exp. 01/2025 is packed as 3000mg 7-count blister packs within a carton for a consumer level. The product is being recalled because it contains undeclared sildenafil.
Sildenafil is an active ingredient in an FDA-approved prescription drug for erectile dysfunction (ED), making the dietary supplement an unapproved new drug. The safety and efficiency of this dietary supplement have not been established, subjecting it to a recall.
Risk Statement
Taking sildenafil unaware of potential drug interactions or health conditions could result in dangerous side effects.
Sildenafil should not be taken with certain medications because it can cause dangerously low blood pressure. People with heart conditions or who are taking medications that interact with sildenafil are at the greatest risk for serious side effects.
Adult males taking nitrates for diabetes, high blood pressure, or heart disease should not take sildenafil. If they do, they’re at risk of experiencing its dangerous side effects such as:
- Dangerously low blood pressure
- Heart attack
- Stroke
- Sudden death
DISTRIBUTOR RFR, LLC. has not received any reports of adverse events related to this product.
The affected products were packaged in a 7-count blister pack within a carton, UPC 0 705632 523285, and distributed in different stores within the state of Florida from 02/01/2002 to 07/20/2022.
Others were distributed Nationwide in the USA through www.sangter.com from 02/01/2002 to 07/20/2022. They were all marked as a dietary supplement for male enhancement.
DISTRIBUTOR RFR, LLC. has issued a notice to all its distributors and customers to stop selling or using and return all affected products. If you have any questions regarding this recall, send an email to [email protected] or call (305) 989-5472, Monday- Friday, from 8:00 AM-5 PM (EDT)
If you have purchased any of these products, please discontinue use immediately and return them to the place of purchase. Consumers should also inform their healthcare providers if they have experienced any adverse reactions associated with the use of these products.
Report any adverse reactions or quality issues through the FDA’s MedWatch Adverse Event Reporting program online or by calling 1- 800-332-1088 to get a report form or fax to 1-800-FDA-0178.
This recall is conducted in cooperation with the U.S. Food and Drug Administration (FDA).
