SANGTER Energy Supplement Capsules Recalled for Undisclosed Sildenafil
Distributor RFR, LLC is recalling SANGTER Energy Supplement Capsules because FDA analysis found they contain undisclosed sildenafil without FDA approval. The product was distributed nationwide and internationally.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification applies. The product is an unapproved drug containing an undisclosed pharmaceutical ingredient (sildenafil) marketed without FDA authorization, meeting the Class I serious health hazard criterion. No deaths or serious injuries are reported in the source.
Plain-English summary
SANGTER Energy Supplement Capsules (3000mg x 7 grain, 7-count blister packs) distributed by Distributor RFR, LLC are being recalled because FDA analysis determined the product contains sildenafil and was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recalled product (Lot 48656, expiration 01/2025, UPC 0 705632 523285) was distributed to retail stores in Florida, nationwide in the United States, and internationally through website sales to France, Canada, and the Bolivarian Republic of Venezuela. Approximately 2000 cartons were distributed.
Consumers who purchased this product should discontinue use immediately and consult their healthcare provider. Those with questions or who wish to report adverse events may contact Distributor RFR, LLC at (800) 519-0204 or contact the FDA.
The recalled product
- Product
- SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285
- Manufacturer
- Distributor RFR, LLC.
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 2,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot: 48656
- Exp. 01/2025
Distribution
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