The Recall Desk
CriticalFDA (Drugs)·D-0455-2024·Announced 2024-05-01

Silverback XXX Power male enhancement product recalled for undeclared sildenafil and tadalafil

Pyramids Wholesale Inc. is recalling Silverback XXX Power male enhancement nationwide due to undeclared sildenafil and/or tadalafil. These prescription drugs were not approved by the FDA before marketing.

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: FDA Class I recall classification, which represents the most serious level of regulatory action. The product was marketed without required FDA approval and contains undeclared prescription medications.

Plain-English summary

Pyramids Wholesale Inc. is recalling Silverback XXX Power male enhancement, 2 fl. oz., nationwide. The product was marketed without the required FDA approval (NDA/ANDA). Testing found that it contains undeclared sildenafil and/or tadalafil, which are prescription medications.

Sildenafil and tadalafil are prescription drugs that must be obtained through medical prescription and pharmacy oversight. Marketing and selling these medications without FDA approval violates federal regulations.

All lots of the product distributed nationwide are affected by this recall.

Consumers who have purchased this product should discontinue use. Contact a healthcare provider if you have questions or concerns.

The recalled product

Product
SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762
Manufacturer
Pyramids Wholesale Inc.
Category
Drug — Male Enhancement
Hazard
  • undeclared-sildenafil-tadalafil

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)

  • All lots

Distribution

Distributed nationwide across the United States.

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