SILINTAN 25/pills Recalled Nationwide Due to Undeclared Meloxicam

FDA Recalls high FDA · · United States

ANTHONY TRINH, 123Herbals LLC has issued a voluntary recall for SILINTAN 25/pills after FDA analysis discovered the presence of undeclared meloxicam.

What Happened

ANTHONY TRINH, 123Herbals LLC is voluntarily recalling SILINTAN 25/pills after an FDA analysis revealed the presence of undeclared meloxicam. The product is also being cited for being marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The FDA has classified this as a Class I recall, indicating a high potential for serious health risks.

Which Products Are Affected

The recall involves the following product:

  • Product Name: SILINTAN 25/pills
  • Packaging: 25-count bottles
  • Manufacturer: Shanghai Chinese Medical Works, Shanghai, China
  • Code Information: All lots within expiry
  • Recall Number: D-0388-2026

The product was distributed nationwide throughout the United States.

What You Should Do

Consumers who possess SILINTAN 25/pills should immediately discontinue use. While the provided data does not list specific refund instructions, consumers may contact the recalling firm, ANTHONY TRINH, 123Herbals LLC, at 7214 Berne St, Rosemead, CA 91770-3844. Healthcare professionals and consumers are encouraged to report any adverse events or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program.

Why This Matters

This recall is significant because meloxicam is a non-steroidal anti-inflammatory drug (NSAID) that was not declared on the product label. Undeclared prescription ingredients can pose serious health risks, particularly if they interact with other medications or are consumed by individuals with specific medical conditions.

Source

FDA Recall Notice - Recall Number D-0388-2026

Source: FDA Official Notice

Frequently Asked Questions

What is this fda recalls alert about?
ANTHONY TRINH, 123Herbals LLC has issued a voluntary recall for SILINTAN 25/pills after FDA analysis discovered the presence of undeclared meloxicam.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.