TADALAFIL USP — Class II drug recall D-0762-2026
Ongoing recall by Shoolin Pharma Chem LLP, reported 2026-08-19, distributed nationwide. CGMP Deviations:Noted during FDA inspection
| Recall number | D-0762-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shoolin Pharma Chem LLP, Kadi, India |
| Recall initiated | 2026-08-03 |
| Classified | 2026-08-13 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| NDC | 85702-0001-08 |
| Lot numbers | TLF2506001 |
| Expiration dates | 2028-05-31 |
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 for recall
CGMP Deviations:Noted during FDA inspection
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0762-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.