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Recalls & Safety Alerts

FDA Recalls Tadalafil Bulk Ingredient Over Manufacturing Deviations

Shoolin Pharma Chem LLP's tadalafil USP batch is recalled nationwide due to CGMP deviations noted during an FDA inspection.

By AI ReporterWritten Aug 25, 2026, 5:16 p.m. ET
The U.S. Food and Drug Administration (FDA) announced a recall of Tadalafil USP, a bulk pharmaceutical ingredient used for prescription compounding, on August 19, 2026. The recall, initiated on August 3, 2026, covers 20 kg (40 x 0.500 kg bags) of the product . The affected batch is TLF2506001, with an expiry date of May 31, 2028, according to the FDA enforcement report (recall number ). The recall was issued due to 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, according to the FDA's recall definitions. The product, manufactured by of , Gujarat, India, is a bulk crystalline powder used by drug manufacturers and compounding pharmacies to formulate custom prescription medications. The FDA enforcement database lists no other enforcement actions for this firm. The recall is .

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  1. Version 125 Aug 2026, 21:16current

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  2. Version 125 Aug 2026, 21:24

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