WEFUN Capsules Recalled: Unapproved Drug with Undisclosed Sildenafil
WEFUN Capsules 825 mg are being recalled due to contamination with sildenafil, an undisclosed active pharmaceutical ingredient not approved for the product. Distribution was nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I, which establishes a minimum severity of 4. Although the source text reports no illnesses or injuries, the undisclosed active pharmaceutical ingredient (sildenafil) without FDA approval for this product presents serious health risks requiring immediate action.
Plain-English summary
WEFUN Capsules 825 mg are being recalled by Hua Da Trading, Inc. dba Wefun Inc. FDA analysis determined the product contains sildenafil, an active ingredient found in FDA-approved medications for male sexual enhancement. This ingredient was not disclosed on the product label, and the product was not approved by FDA through a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The presence of this undisclosed pharmaceutical ingredient makes WEFUN Capsules an unapproved drug. Consumers may be exposed to uncontrolled doses of sildenafil without their knowledge or medical supervision.
The recalled product was distributed nationwide in the United States. The affected units are identified by Lot #18520168 with an expiration date of 09/30/2026. A total of 300 cartons were distributed.
Consumers who have purchased this product should stop using it immediately and consult a healthcare provider with questions about product safety or any adverse health effects from use.
The recalled product
- Product
- WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
- Manufacturer
- Hua Da Trading, Inc. dba Wefun Inc.
- Category
- Drug
- Affected units
- 300
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 (2)
- Lot # #18520168
- Exp. date 09/30/2026 .
Distribution
Distributed nationwide across the United States.
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