Evil Root 1200 mg Recalled for Undeclared Sildenafil
Fabscout Entertainment, Inc. is recalling Evil Root 1200 mg capsules because the product contains undeclared sildenafil and was marketed without FDA approval.
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: The agency classification is FDA Class I, which indicates a reasonable probability that use of or exposure to the violative product will cause serious adverse health consequences or death.
Plain-English summary
Fabscout Entertainment, Inc. is recalling 32 bottles of Evil Root 1200 mg, each containing 6 capsules. The product was manufactured by Tibet Shengyang Health Medicine Co., Ltd. and distributed in California, Florida, and Utah. All lots are affected by this recall.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and was found to contain undeclared sildenafil. Sildenafil is a prescription medication used to treat erectile dysfunction, and its presence in an unapproved dietary supplement poses a safety risk to consumers who may not be aware of the active pharmaceutical ingredient.
Consumers who have purchased Evil Root 1200 mg should stop using the product immediately. They should contact Fabscout Entertainment, Inc. for further instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Evil Root 1200 mg, supplied in 6 capsules per bottle, Manufacturer: Tibet Shengyang Health Medicine Co.,Ltd. Address: No. 98, Min zu Road, Lhasa
- Manufacturer
- Fabscout Entertainment, Inc
- Category
- Drug — Dietary Supplement
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
Part of a larger recall action
This product is one of 3 recalled by Fabscout Entertainment, 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 3 products in this recall →Related recalls
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