FDA Recalls Unapproved Black Ant Capsules Containing Sildenafil
A&H Focal Inc. is recalling Black Ant capsules found to contain sildenafil, an unapproved drug with unestablished safety and efficacy.
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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall corresponds to a score of 4 (Severe), particularly given the presence of an unapproved active pharmaceutical ingredient.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Black Ant capsules, 4600mg, 4-count blister packs, manufactured by A&H Focal Inc. The product labeling is in a foreign language. The recall is being conducted because FDA analysis determined that the capsules contain sildenafil, a drug approved by the FDA for the treatment of erectile dysfunction.
Because the product contains sildenafil 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 by the FDA. The agency has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected products were distributed in New York and New Jersey through six retail stores identified as "Asian Food Markets." All lots of the product are subject to this recall. Consumers who possess these products should stop using them and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
- Manufacturer
- A&H Focal Inc.
- Category
- Drug — Unapproved 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 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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