FDA Drug recall D-0759-2026
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no…
- FDA Drug
- Class II
- ongoing
- Published 2026-08-19
On 2026-08-19 the FDA classified a Class II recall of SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no… by Shoolin Pharma Chem, citing CGMP Deviations:Noted during FDA inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0759-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-03 |
| Published | 2026-08-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Shoolin Pharma Chem |
| Distribution | US |
Product
SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05
Reason
CGMP Deviations:Noted during FDA inspection
Identifiers
| code_info | Batch SDC2505001, Date of Expiry: April 30, 2030. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0759-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.