FDA Recalls Sildenafil Citrate API Over Manufacturing Deviations

Shoolin Pharma Chem LLP's sildenafil citrate active ingredient is recalled nationwide due to CGMP deviations found during an FDA inspection.

By AI ReporterWritten Aug 25, 2026, 5:54 p.m. ET

The U.S. Food and Drug Administration (FDA) announced a recall of sildenafil citrate active pharmaceutical ingredient (API) manufactured by , based in , India. The recall, initiated on August 3, 2026, and reported on August 19, 2026, covers 25 kg (250 1-gm bags) of the product . The affected batch is SDC2505001, with an expiry date of April 30, 2030, and NDC 85702-001-05. The recall was prompted 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 , and the FDA enforcement report lists recall number . Sildenafil citrate is a bulk raw material used by licensed pharmaceutical manufacturers and compounding pharmacies to formulate finished prescription medications. The FDA's enforcement database records no other enforcement actions for this firm.

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