The Recall Desk
CriticalFDA (Drugs)·D-0959-2016·Announced 2016-06-15

Fuel Up Plus capsules recalled for undeclared sildenafil analogue

Reesna, Inc. is recalling Fuel Up Plus capsules marketed as a dietary supplement because they contain undeclared hydroxythiohomosildenafil, an analogue of the ED 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 per the rubric.

Plain-English summary

Reesna, Inc. is recalling Fuel Up Plus capsules in 1-count, 5-count, and 10-count packages. The product was marketed as a dietary supplement but was found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED). This makes the product an unapproved new drug.

The recall covers 26,250 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 PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM
Manufacturer
Reesna, Inc
Affected units
26,250

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 →

Same manufacturer · Reesna, Inc

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