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.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
- Affected units
- 7
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.
Part of a larger recall action
This product is one of 11 recalled by Pyramids Wholesale 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 11 products in this recall →Related recalls
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