Shoolin Pharma Chem recalls
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Shoolin Pharma Chem and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-08-19FDA-DrugClass IIShoolin Pharma Chem sildenafil citrate recalled for manufacturing violations
The FDA identified Current Good Manufacturing Practice (CGMP) deviations during an inspection of Shoolin Pharma Chem LLP, a supplier of sildenafil citrate USP—an active pharmaceutical ingredient used in prescription compounding. One lot (SDC2505001) distributed nationwide has been recalled due to these manufacturing control issues.
- 2026-08-19FDA-DrugClass IIShoolin Pharma tadalafil powder recalled for manufacturing violations
The FDA identified manufacturing practice violations (CGMP deviations) during an inspection of Shoolin Pharma Chem's facility in India. One batch of tadalafil USP powder used for prescription compounding was distributed nationwide in the USA and does not meet required manufacturing standards.
- 2026-08-19FDA-DrugClass IIShoolin Pharma tadalafil USP recalled for manufacturing deviations
The FDA identified current good manufacturing practice (CGMP) deviations during an inspection of Shoolin Pharma Chem LLP's facility in India. The company manufactures tadalafil USP powder (active pharmaceutical ingredient) intended for prescription compounding use. One batch (TLF2506001, expiring May 31, 2028) totaling 20 kg was distributed nationwide in the USA.
- 2026-08-19FDA-DrugClass IIShoolin Pharma tadalafil USP recalled for manufacturing violations
Shoolin Pharma Chem LLP's tadalafil USP powder (lot TLF2506001) was found to have deviations from good manufacturing practices during an FDA inspection. The affected product is a 100-gram bag intended for prescription compounding only.
- 2026-08-19FDA-DrugClass IIShoolin Pharma sildenafil citrate recalled for manufacturing deviations
The FDA identified Current Good Manufacturing Practice (CGMP) deviations during an inspection of Shoolin Pharma Chem LLP's facility in India. Sildenafil citrate bulk powder (batch SDC2505001, expiring April 30, 2030) distributed nationwide for prescription compounding did not meet required manufacturing standards.
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