Unapproved Ye Lang Shen capsules containing sildenafil recalled by FDA
A&H Focal Inc. is recalling Ye Lang Shen capsules because FDA analysis found they contain sildenafil, an unapproved drug for which safety and efficacy have not been established.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score per the rubric.
Plain-English summary
A&H Focal Inc. is recalling Ye Lang Shen capsules, 5000 mg, 8-count bottles, because FDA analysis found the products contain sildenafil. Sildenafil is an FDA-approved drug for the treatment of erectile dysfunction. Because these capsules contain this active ingredient 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 recalled product has labeling in a foreign language. The recall covers all lots of the product. The capsules were distributed in New York and New Jersey through six retail stores named "Asian Food Markets."
Consumers who have purchased these products should stop using them and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language
- Manufacturer
- A&H Focal Inc.
- Category
- Drug — Unapproved Drug
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
- CriticalFDA Recalls Unapproved Sildenafil Tablets Sold in Asian Food Markets
FDA (Drugs) · 2018-02-07
- SevereUnapproved herbal capsules containing sildenafil recalled by FDA
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