FDA Recalls Unapproved MAX MAN Capsules Containing Sildenafil
A&H Focal Inc. is recalling MAX MAN capsules sold in New York and New Jersey because they contain sildenafil, an unapproved drug with unestablished safety and efficacy.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, which corresponds to a Severe severity score (4) according to the rubric, as it involves a significant health risk where adverse health consequences are possible.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for MAX MAN capsules, 3000 mg, 6-count bottles. The product is manufactured by A&H Focal Inc. and features labeling in a foreign language. The recall covers all lots of the product.
The FDA determined that these products contain sildenafil, a drug approved for the treatment of erectile dysfunction. Because the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), they are considered unapproved drugs. Consequently, the safety and efficacy of these specific products have not been established.
The affected products were distributed in New York and New Jersey through six retail stores identified as "Asian Food Markets." Consumers who purchased these products should stop using them and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- MAX MAN capsules, 3000 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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