D-0388-2026 Class I Ongoing
FDA drug recall D-0388-2026 was initiated by ANTHONY TRINH, 123Herbals LLC on October 20, 2025 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- March 11, 2026
- Initiation Date
- October 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Distribution Pattern
USA nationwide
Code Information
All lots within expiry