FDA Reports Recall of Sildenafil Citrate USP Bulk Ingredient on August 19, 2026
The FDA's enforcement report dated August 19, 2026, details a Class II recall of sildenafil citrate bulk ingredient distributed nationwide, citing manufacturing deviations.
2 reports on this incident · first at Aug 26, 2026, 8:07 p.m. ET
Earlier reports
Aug 26, 2026, 8:07 p.m. ETFirst report
FDA Recalls Sildenafil Citrate USP Bulk Ingredient Over Manufacturing Deviations
The U.S. Food and Drug Administration (FDA) announced a Class II recall of Sildenafil Citrate USP, a bulk active pharmaceutical ingredient used in prescription compounding, on August 19, 2026. The recall, initiated August 3, 2026, covers 25 kg (25 x 1.00 kg bags) distributed nationwide in the USA. The product is labeled with lot SDC2505001, expiry April 30, 2030, and NDC 85702-001-08.
The recall was prompted by current Good Manufacturing Practice (CGMP) deviations noted during an FDA inspection, according to the FDA enforcement report (recall number D-0763-2026). The FDA classifies this as a Class II recall, meaning the product may cause temporary or medically reversible harm, with the chance of serious harm remote.
The product is a bulk ingredient sold to licensed formulators and compounding pharmacies, not directly to consumers. The FDA's enforcement database lists no other enforcement actions by Shoolin Pharma Chem LLP. The recall is ongoing.
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- Version 127 Aug 2026, 00:07current
First published.
- Version 127 Aug 2026, 00:24current
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