Supplements Under Class I Recall

All lots of Vail-Bon Jie Yang Wan capsules from 123Herbals are under a Class I recall for being tainted with the undeclared dexamethasone and chlorpheniramine, according to the October 16, 2024, US Food and Drug Administration (FDA) Enforcement Report. The administration’s most serious recall classification, the designation warns use of the product could cause serious adverse health consequences or death.

Because of the drug ingredient dexamethasone, a corticosteroid, long-term use of the capsules at the recommended dose of 6 capsules daily could cause numerous severe or life-threatening adverse events, including but not limited to adrenal suppression, central nervous system and psychiatric/behavioral effects, weight gain, gastrointestinal effects, elevated blood glucose, increased infection risks, neuromuscular and skeletal side effects, ocular effects, cardiovascular effects, and dermatologic effects, 123Herbals stated in a September 18, 2024, company announcement. 

Chlorpheniramine, an antihistamine, could potentially cause overexcitement, loss of coordination, drowsiness, loss of consciousness, and seizures.

“To date, 123Herbals has not received any reports of adverse events related to this recall,” the announcement stated.

Vail-Bon Jie Yang Wan capsules are packaged in 30-count plastic bottles and marketed on the 123Herbals website and at online retailers including Amazon for the treatment of skin disease, eczema, and itch. The product has been distributed throughout the United States.

123Herbals voluntarily initiated the recall September 18, 2024. The FDA issued its Class I designation October 10, 2024.