FDA Recalls Unapproved Sildenafil Tablets Sold in Asian Food Markets
A&H Focal Inc. is recalling LANG YI HAO CHAONONGSUOPIAN tablets because they contain sildenafil without FDA approval. The products were sold in New York and New Jersey.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottles, manufactured by A&H Focal Inc. The product labeling is in a foreign language. The recall is classified as Class I.
The FDA determined that these products contain sildenafil, a drug approved for the treatment of erectile dysfunction. Because the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), they are considered unapproved drugs for which safety and efficacy have not been established.
The affected products were distributed in New York and New Jersey through six retail stores named "Asian Food Markets." All lots are subject to the recall. Consumers should stop using the product and return it to the place of purchase.
The recalled product
- Product
- LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language
- Manufacturer
- A&H Focal Inc.
- Category
- Drug — Unapproved Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 21 recalled by A&H Focal Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
Same manufacturer · A&H Focal Inc.
See all →- SevereFDA Recalls Unapproved Miraculous Evil Root Capsules Containing Sildenafil
FDA (Drugs) · 2018-02-07
- SevereFDA Recalls Unapproved Gold Vigra Capsules Containing Sildenafil
FDA (Drugs) · 2018-02-07
- SevereFDA Recalls Unapproved Power V8 Viagra Tablets Containing Sildenafil
FDA (Drugs) · 2018-02-07
- SevereUnapproved herbal capsules containing sildenafil recalled by FDA
FDA (Drugs) · 2018-02-07
- SevereFDA Recalls MACA Gold Tablets Containing Unapproved Sildenafil
FDA (Drugs) · 2018-02-07
Same hazard · unapproved drug
See all →- CriticalBuy-Herbal Recalls Kian Pee Wan Capsules for Undeclared Drug Ingredients
FDA (Drugs) · 2026-08-19
- SevereMR. 7 Super capsules recalled as Class I over undeclared sildenafil
FDA (Drugs) · 2026-03-11
- SevereMojo Max Fusion capsules recalled as Class I over undeclared drug ingredients
FDA (Drugs) · 2026-03-11
- SevereSilintan herbal pills recalled as Class I for undeclared meloxicam
FDA (Drugs) · 2026-03-11
- SevereAgebox iKids-Growth Day Formula Capsules Recalled Over Undeclared Drug Ingredient
FDA (Drugs) · 2026-03-04