FDA Drug Recalls

Recalls / Class I

Class ID-0388-2026

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

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

Affected lot / code info
All lots within expiry

Why it was recalled

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.

Recalling firm

Firm
ANTHONY TRINH, 123Herbals LLC
Notification channel
Press Release
Type
Voluntary: Firm initiated
Address
7214 Berne St, N/A, Rosemead, California 91770-3844

Distribution

Quantity
N/A
Distribution pattern
USA nationwide

Timeline

Recall initiated
2025-10-20
FDA classified
2026-03-13
Posted by FDA
2026-03-11
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0388-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class I recall: drug · FDA Drug Recalls