Drug FDA Class I Ongoing Mislabeling
Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.
123Herbals Published Oct 16, 2024
Risk level
Class IDangerous or defective — could cause serious health problems or death.
Severity score 75/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact 123Herbals or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
Hazards
Undeclared Dexamethasone · primaryUndeclared Chlorpheniramine
Affected products (1)
Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.
unknown
Lot codes: within
Code info: All lots within expiry
Affected areas
Distributed via Amazon and 123Herbals.com website
Timeline
- InitiatedSep 18, 2024
- PublishedOct 16, 2024
- Recall number
- D-0008-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.