SILINTAN 25 Pills Class I Recall Issued by FDA

FDA has classified a Class I recall for SILINTAN 25 pills, a dietary/herbal supplement, due to the presence of undeclared meloxicam and marketing without FDA approval. The product was distributed nationwide in 25-count bottles manufactured by Shanghai Chinese Medical Works in China. This represents a serious regulatory violation as the presence of an undeclared pharmaceutical ingredient poses significant health risks to consumers who may be unknowingly ingesting meloxicam, which can cause serious gastrointestinal bleeding and cardiovascular events.

Pharmaceutical companies, drug manufacturers, healthcare providers, and consumers holding SILINTAN 25 pills should cease use immediately. Class I is the most serious FDA recall classification, indicating reasonable probability that use of the product will cause serious adverse health consequences or death. The voluntary nature of the recall does not diminish the binding compliance obligations for distributors and retailers in the supply chain to remove affected products from commerce.