Shoolin Pharma Chem: multiple drugs
Shoolin Pharma Chem recalls Sildenafil and Tadalafil APIs due to CGMP deviations.
If you are a pharmacy or healthcare provider that received these APIs, stop using them immediately and contact Shoolin Pharma Chem LLP for return and replacement instructions. Consumers who have prescriptions compounded with these ingredients should contact their pharmacist or healthcare provider.
Why it was recalled
Shoolin Pharma Chem LLP is recalling Sildenafil Citrate USP and Tadalafil USP active pharmaceutical ingredients (APIs) used in prescription compounding due to CGMP deviations noted during an FDA inspection. The products were distributed in the USA.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Lot code | NDC / UPC | Recall # |
|---|---|---|---|
| SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem… | SDC2505001, 2030 | NDC 85702-001-05 | D-0759-2026 |
| TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP… | TLF2506001, 2028 | NDC 85702-002-02 | D-0760-2026 |
| SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem… | SDC2505001, 2030 | NDC 85702-001-08 | D-0763-2026 |
| TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP… | TLF2506001, 2028 | NDC 85702-002-04 | D-0761-2026 |
| TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP… | TLF2506001, 2028 | NDC 85702-001-08 | D-0762-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Manufacturing Deviation recalls
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification