Drug recall: Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
A&H Focal Inc. (Staten Island, NY) initiated this drug recall on 7 Mar 2017; FDA lists 21 product records under event 76644, classified Class I.
FDA defines Class I as 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. 13% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 14 Jun 2019. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for A&H Focal Inc..
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
A&H Focal Inc., Staten Island, NY.
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."
Distribution
"NY and NJ through six retail stores named "Asian Food Markets""
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0552-2018 | Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language | unknown | Class II | Terminated | 7 Feb 2018 |
| D-0553-2018 | Indian God Lotion Spray Bottle, labeling is in foreign language | unknown | Class III | Terminated | 7 Feb 2018 |
| D-0554-2018 | Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0555-2018 | GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0556-2018 | GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0557-2018 | HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language | unknown | Class II | Terminated | 7 Feb 2018 |
| D-0558-2018 | LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0559-2018 | GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0560-2018 | Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0561-2018 | Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language | unknown | Class II | Terminated | 7 Feb 2018 |
| D-0562-2018 | ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0563-2018 | Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0564-2018 | STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language | unknown | Class II | Terminated | 7 Feb 2018 |
| D-0565-2018 | MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language | unknown | Class II | Terminated | 7 Feb 2018 |
| D-0566-2018 | HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0567-2018 | YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0568-2018 | Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0569-2018 | DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0570-2018 | LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0571-2018 | MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language | unknown | Class I | Terminated | 7 Feb 2018 |
| D-0572-2018 | Tiger King tablets, labeling is in foreign language | unknown | Class II | Terminated | 7 Feb 2018 |
Context
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "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."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "NY and NJ through six retail stores named "Asian Food Markets""
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Jun 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.