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123Herbals was cited for manufacturing and selling unapproved new drugs including SILINTAN, Ganoderma Huo Luo Dan, Hong Kong Vail Bon Tong, SAM NHUNG BO THAN, TDCARE, and Vall Boon Antacid in violation of sections 505(a) and 301(d) of the FD&C Act. FDA laboratory analysis of SILINTAN revealed it contained the undeclared active pharmaceutical ingredient meloxicam, an NSAID that poses serious safety risks including cardiovascular events, gastrointestinal bleeding, and potentially fatal complications, along with hazardous drug-drug interactions. The SILINTAN product was also found to be misbranded under section 502 of the FD&C Act. The violations were identified during FDA's review of the company's website between July and November 2025.