FDA Drug recall D-0562-2018
ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language
- FDA Drug
- Class I
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class I recall of ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language by A And H Focal, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0562-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-03-07 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | A And H Focal |
| Distribution | NJ, NY |
Product
ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language
Reason
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.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0562-2018%22
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