Shoolin Pharma Chem LLP SILDENAFIL CITRATE USP 0.1 KG RX ONLY Recall
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 |
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.
How to identify the recalled item
| Lot / date codes | Batch TLF2506001, Date of Expiry: May 31, 2028. |
|---|---|
| Lot / date codes | Batch SDC2505001, Date of Expiry: April 30, 2030. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.