Fuel Up High Octane capsules recalled for undeclared sildenafil analogue
Reesna, Inc. is recalling Fuel Up High Octane capsules because they contain undeclared hydroxythiohomosildenafil, an analogue of the prescription drug Sildenafil.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Reesna, Inc. is recalling Fuel Up High Octane capsules in 1-count, 5-count, and 10-count packages. The products were marketed as dietary supplements but were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male erectile dysfunction. This makes the products unapproved new drugs.
The recall involves 7,250 capsules with an expiration date of 12/18. The products were distributed nationwide and in the United Kingdom.
Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
- Manufacturer
- Reesna, Inc
- Category
- Drug — Dietary Supplement
- Affected units
- 7,250
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 (1)
- Exp. 12/18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Reesna, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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