FDA Recall D-0008-2025

123Herbals · Rosemead, CA

Class I — life-threatening Ongoing 603 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.

Lot / code: All lots within expiry

Quantity: unknown

Reason for recall

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.

Recall record

Recall number: D-0008-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Distributed via Amazon and 123Herbals.com website
Recall initiated: 2024-09-18
Classified by FDA Center: 2024-10-10
FDA published: 2024-10-16
Recalling firm: 123Herbals
Firm location: Rosemead, CA

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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