Agency classClass IIOur severity:Severe FDA (Drugs)·D-0552-2018·Announced 2018-02-07

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.

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 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
Hazard: unapproved-drug
sildenafil

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

Distributed in 2 states:

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.

See all 21 products in this recall →

Same manufacturer · A&H Focal Inc.

See all →

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Severe
FDA Recalls Unapproved Power V8 Viagra Tablets Containing Sildenafil
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Critical
FDA Recalls Unapproved Sildenafil Tablets Sold in Asian Food Markets
FDA (Drugs) · 2018-02-07
Severe
Unapproved herbal capsules containing sildenafil recalled by FDA
FDA (Drugs) · 2018-02-07

Same hazard · unapproved drug