A&H Focal Zhonghua Niubian Tablets: Unapproved Sildenafil Risk
FDA recalls A&H Focal's Zhonghua Niubian 2000mg tablets due to unapproved sildenafil content. These foreign-labeled tablets lack FDA approval for safety and efficacy.
Recall notice
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.
Contact the company
What happened, in plain English
A&H Focal is recalling Zhonghua Niubian tablets (2000mg, 6-count bottles) because they contain sildenafil without FDA approval. This makes them unapproved drugs with unknown safety and effectiveness. Read more at govinfonow.com/recall/41823-a-h-focal-zhonghua-niubian-tablets-unapproved-sildenafil-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41823-a-h-focal-zhonghua-niubian-tablets-unapproved-sildenafil-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0563-2018
Cite this page
“A&H Focal Zhonghua Niubian Tablets: Unapproved Sildenafil Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41823-a-h-focal-zhonghua-niubian-tablets-unapproved-sildenafil-risk. Based on FDA recall #D-0563-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0563-2018%22&limit=1).
Why it’s dangerous
These tablets contain sildenafil, an FDA-approved drug for erectile dysfunction, but were not approved for sale in the U.S. The FDA found they lack safety and efficacy data, meaning risks like side effects or harm are unknown.
Who’s affected
Anyone who owns or uses these tablets. People most at risk are those taking them for erectile dysfunction without medical supervision.
How to tell if you have this one
Check for Zhonghua Niubian tablets labeled in foreign language, 2000mg strength, 6-count bottles. All lots are affected.
- Brand
A&H Focal- Category
Drug
All 21 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Status
Terminated- Distribution
NY and NJ through six retail stores named "Asian Food Markets"
| Recall number | Product, codes & lots | Class |
|---|---|---|
| D-0552-2018 | Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language; All Lots | Class II |
| D-0553-2018 | Indian God Lotion Spray Bottle, labeling is in foreign language; All Lots | Class III |
| D-0554-2018 | Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language; All Lots | Class I |
| D-0555-2018 | GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language; All Lots | Class I |
| D-0556-2018 | GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language; All Lots | Class I |
| D-0557-2018 | HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language; All Lots | Class II |
| D-0558-2018 | LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language; All Lots | Class I |
| D-0559-2018 | GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language; All Lots | Class I |
| D-0560-2018 | Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language; All Lots | Class I |
| D-0561-2018 | Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language; All Lots | Class II |
| D-0562-2018 | ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language; All Lots | Class I |
| D-0563-2018 | Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language; All Lots | Class I |
| D-0564-2018 | STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language; All Lots | Class II |
| D-0565-2018 | MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language; All Lots | Class II |
| D-0566-2018 | HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language; All Lots | Class I |
| D-0567-2018 | YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language; All Lots | Class I |
| D-0568-2018 | Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language; All Lots | Class I |
| D-0569-2018 | DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language; All Lots | Class I |
| D-0570-2018 | LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language; All Lots | Class I |
| D-0571-2018 | MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language; All Lots | Class I |
| D-0572-2018 | Tiger King tablets, labeling is in foreign language; All Lots | Class II |
What to do — step by step
Check Product Label
Look for foreign-language labeling on the tablet bottle.
Where it went and when
Where it was distributed
Distributed in New Jersey and New York.
FDA distribution: “NY and NJ through six retail stores named "Asian Food Markets"” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Jersey, New York.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class I
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0563-2018 (March 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0563-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.