STREE OVERLORD capsules recalled for containing unapproved sildenafil
A&H Focal Inc. is recalling STREE OVERLORD capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or structural defects are Severe; while no specific injuries are reported, the presence of an unapproved active pharmaceutical ingredient (sildenafil) in a product lacking safety/efficacy data aligns with the higher risk profile of Class II drug recalls.
Plain-English summary
A&H Focal Inc. is recalling STREE OVERLORD capsules, 3800 mg, 4-count bottles. The product labeling is in a foreign language. The recall covers all lots of the product.
The FDA determined that the capsules contain sildenafil, a drug approved by the FDA for the treatment of erectile dysfunction. Because the product was marked without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), it is considered an unapproved drug. The safety and efficacy of these specific capsules have not been established.
The product was distributed in New York and New Jersey through six retail stores named "Asian Food Markets." Consumers who purchased this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- STREE OVERLORD capsules, 3800 mg, 4-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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