FDA Recalls Unapproved Miraculous Evil Root Capsules Containing Sildenafil
A&H Focal Inc. is recalling Miraculous Evil Root capsules because FDA analysis found they contain sildenafil, an unapproved drug with unestablished safety and efficacy.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
A&H Focal Inc. is recalling Miraculous Evil Root capsules, 1200 mg, 6-count bottles, because the products are marked without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The products were sold in New York and New Jersey through six retail stores named "Asian Food Markets." The labeling on the bottles is in a foreign language.
The FDA conducted an analysis of the products and found that they contain sildenafil, a drug approved by the FDA for the treatment of erectile dysfunction. Because the products contain this active pharmaceutical ingredient without proper approval, they are considered unapproved drugs for which safety and efficacy have not been established.
Consumers who have purchased these products should stop using them and return them to the place of purchase or contact the recalling firm for further instructions.
The recalled product
- Product
- Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language
- Manufacturer
- A&H Focal Inc.
- Category
- Drug — Unapproved Drug
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 21 recalled by A&H Focal 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.
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