FDA Recalls Tadalafil USP Bulk Ingredient Over CGMP Deviations

Shoolin Pharma Chem LLP's tadalafil bulk ingredient is recalled nationwide due to manufacturing deviations noted during an FDA inspection.

By AI ReporterWritten Aug 25, 2026, 4:23 p.m. ET

The U.S. Food and Drug Administration (FDA) announced a recall of Tadalafil USP, a bulk active pharmaceutical ingredient used in prescription compounding, distributed nationwide. The recall, initiated on August 3, 2026, and reported on August 19, 2026, covers lot TLF2506001 with an expiry date of May 31, 2028. The product is packaged in 0.1 kg (100 gm) bags, with a total quantity of 1 kg (100 bags), and is labeled with NDC 85702-002-02. The recall was triggered by current Good Manufacturing Practice (CGMP) deviations noted during an FDA inspection. The FDA classifies this as a recall, meaning the product may cause temporary or medically reversible harm, with the chance of serious harm remote. The recall is . The product is manufactured by , located in , Gujarat, India. According to the FDA enforcement report (recall number ), the FDA's database records no other enforcement actions against this firm. The recall is a precautionary measure; no adverse events have been reported in the record.

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