Zhonghua Niubian tablets — Class I drug recall D-0563-2018
Terminated recall by A&H Focal Inc., reported 2018-02-07, distributed in NJ, NY. Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved
| Recall number | D-0563-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | A&H Focal Inc., Staten Island, NY, United States |
| Recall initiated | 2017-03-07 |
| Classified | 2018-02-28 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2019-06-14 |
| Distributed | NJ, NY |
| Reason classes | unapproved product |
Product
Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0563-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.