SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China

Recall Insight

This FDA Drug action (record #D-0388-2026) was formally reported on March 11, 2026, with the manufacturer initiating the action on October 20, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. ANTHONY TRINH, 123Herbals LLC is listed as the recalling firm, operating out of Rosemead, CA. Federal records indicate N/A units are affected.

The documented reason for this recall is: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. Distribution data in the federal record shows the product reached: USA nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.