SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
Summary
The FDA issued a Class I for SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works by ANTHONY TRINH, 123Herbals LLC. Reason: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam..
Details
Source
Drug Recall
External ID
D-0388-2026
Action Date
2026-03-11
Status
Ongoing
Category
drug
Product Description
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
Lot/Code Info: All lots within expiry
Quantity Affected: N/A
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Distribution
USA nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-20
Company
Rosemead, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 85 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ANTHONY TRINH, 123Herbals LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ANTHONY TRINH, 123Herbals LLC have FDA actions?
This is the only FDA action we have on record for ANTHONY TRINH, 123Herbals LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0388-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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