CLASS II Drug recall · Reported 7 Feb 2018 · FDA Enforcement Report
Black Ant capsules, 4600mg, labeling is in foreign language recalled
A&H Focal is recalling Black Ant capsules, 4600mg, labeling is in foreign language, distributed in New Jersey, New York. The recall was initiated on 7 Mar 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0552-2018
- FDA event ID
- 76644
- Recalling firm
- A&H Focal, Staten Island, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Mar 2017
- FDA classified
- 28 Feb 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Hidden Drug Ingredients
Timeline
| 7 Mar 2017 | Recall initiated by company | |
| 7 Feb 2018 | Published in enforcement report | +337 days |
| 28 Feb 2018 | Classified by FDA | +21 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
Where it was distributed
NY and NJ through six retail stores named "Asian Food Markets"
Questions about this recall
Why was it recalled?
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Which lots are affected?
All Lots
Where was it sold?
NY and NJ through six retail stores named "Asian Food Markets"
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
20 other products · FDA event 76644This product is part of a recall event; the main page for the event is Zhonghua Niubian tablets, 2000mg, labeling is in foreign language recalled.
More recalls from A&H Focal
All 21Other Black Ant recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Black Ant, 2800 mg, four capsules recalled by Eugene Oregon | Eugene Oregon | Labeling Errors | 11 states |
| Drug | CLASS I | Black Ant, 4600 mg, four capsules recalled by Nova Products | Nova Products | Labeling Errors | Nationwide |
| Drug | CLASS I | Black Ant, 4600 mg x Product recalled by American Lifestyle.Com | American Lifestyle.Com | Labeling Errors | NY |