Black Ant capsules recalled for undeclared sildenafil
Eugene Oregon, Inc. is recalling Black Ant capsules because FDA testing found undeclared sildenafil. The product was marketed without an approved NDA or ANDA.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Eugene Oregon, Inc. is recalling 136 boxes of Black Ant, 2800 mg, four capsules per box. The product was manufactured by Qinghai Baojiantang Pharmaceutical Co., Ltd. and distributed to retailers in Maryland, Texas, Florida, Pennsylvania, Illinois, New Jersey, Indiana, Louisiana, Washington, Maine, and South Carolina.
The recall was initiated because FDA laboratory analyses determined that the capsules contain undeclared sildenafil. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd.
- Manufacturer
- Eugene Oregon, Inc.
- Category
- Drug — Supplement
- Affected units
- 136
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 3 recalled by Eugene Oregon, 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 3 products in this recall →Related recalls
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