Shoolin Pharma Chem LLP SILDENAFIL CITRATE USP 0.1 KG RX ONLY Recall (Unknown Month Year)
Announced 2026-08-19 · FDA
FDA recalls Shoolin Pharma Chem LLP SILDENAFIL CITRATE USP 0.1 KG RX ONLY (for Prescription Compounding Only) distributed nationwide in the USA due to CGMP deviations noted during an FDA inspection. The batch is TLF2506001 with expiry May 31, 2028, and the recall covers 1 KG total (20 x 1 KG bags).
| Brand | Shoolin Pharma Chem LLP |
|---|---|
| Product | TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08 |
| Reason | CGMP Deviations:Noted during FDA inspection |
| Severity | moderate |
| Units affected | 25 |
| Distribution | Distributed Nationwide in the USA |
| Agency | FDA |
| Recall / campaign no. | Batch TLF2506001, Date of Expiry: May 31, 2028. |
WHAT YOU SHOULD DO
- Stop using all units from batch TLF2506001 immediately.
- Contact your dispensing pharmacy or supplier to arrange return, disposal, or replacement per recall instructions.
- If you have used the product and experienced adverse effects, seek medical advice and report to a health professional and FDA MedWatch.
- Monitor FDA recall notices for updates and follow any additional instructions.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.