FDA Recalls Hard Ten Days Capsules for Unapproved Sildenafil
The FDA is recalling Hard Ten Days Capsules because they contain sildenafil, an unapproved active ingredient. Consumers should stop using the product.
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 per the rubric mandates a severity score of 5 (Critical) regardless of other factors.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Hard Ten Days Capsules, 4500 mg, boxes of 6 packets. The product is marketed as an over-the-counter (OTC) item developed by American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company. The recall is being conducted by www.vitaminbestbuy.com.
The recall is issued because the product contains sildenafil, a prescription medication, without an approved Abbreviated New Drug Application (ANDA) or New Drug Application (NDA). The source text does not specify the number of affected units, specific lot numbers, or the geographic distribution of the product.
Consumers who have purchased Hard Ten Days Capsules should stop using the product immediately. The source text does not provide specific instructions for returning the product or seeking a refund.
The recalled product
- Product
- Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet
- Manufacturer
- www.vitaminbestbuy.com
- Affected units
- 550
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 3 recalled by www.vitaminbestbuy.com 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 3 products in this recall →Related recalls
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