SILDENAFIL CITRATE USP recall
FDA recall D-0759-2026 · initiated Aug 3, 2026
Shoolin Pharma Chem LLP recalled SILDENAFIL CITRATE USP in Aug 2026 — an FDA Class II recall (D-0759-2026) because CGMP Deviations:Noted during FDA inspection.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations:Noted during FDA inspection
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 25KG, 250-1gm bags
Details
- 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
- Recalling company
- Shoolin Pharma Chem LLP
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Aug 3, 2026
- FDA report date
- Aug 19, 2026
Frequently asked
- Was SILDENAFIL CITRATE USP recalled?
- Shoolin Pharma Chem LLP recalled SILDENAFIL CITRATE USP in Aug 2026 — an FDA Class II recall (D-0759-2026) because CGMP Deviations:Noted during FDA inspection. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was SILDENAFIL CITRATE USP recalled?
- Per the FDA enforcement record, the reason for recall D-0759-2026 was: CGMP Deviations:Noted during FDA inspection
- Is a recalled SILDENAFIL CITRATE USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of SILDENAFIL CITRATE USP are affected?
- Distributed: Distributed Nationwide in the USA. The recall covers these lots — Batch SDC2505001, Date of Expiry: April 30, 2030.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0759-2026.