FDA Drug recall D-0561-2018
Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language
- FDA Drug
- Class II
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of Ye Lang Shen capsules, 5000 mg, 8-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-0561-2018 |
| Classification | Class II |
| 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
Ye Lang Shen capsules, 5000 mg, 8-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-0561-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.