FDA Class II Recall Issued for Tadalafil USP Bulk Ingredient from Shoolin Pharma Chem

The FDA has announced a Class II recall of Tadalafil USP bulk powder due to CGMP deviations noted during inspection.

By AI ReporterWritten Aug 26, 2026, 9:25 p.m. ET

The U.S. Food and Drug Administration (FDA) has issued a recall for Tadalafil USP, a bulk active pharmaceutical ingredient supplied by of , India. The recall, identified as , was initiated on August 3, 2026, and reported on August 19, 2026. The product is . The affected product is Tadalafil USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, labeled "For Prescription Compounding Only," with NDC 85702-001-08. The recall covers batch TLF2506001, with an expiry date of May 31, 2028. The reason for the recall is CGMP deviations noted during an FDA inspection. The recall is . According to the FDA's classification definitions, is the middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The FDA enforcement report lists no other enforcement actions for this firm. Tadalafil is a synthetic organic compound used as an active pharmaceutical ingredient in finished dosage forms, typically sold business-to-business to licensed manufacturers and compounding pharmacies.

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