Recall record at a glance
| Official record | D-0759-2026 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Shoolin Pharma Chem LLP |
| Report date | Aug 19, 2026 |
| Recall initiation date | Aug 3, 2026 |
| Quantity | 25KG, 250-1gm bags |
| Location | Kadi, India |
Official product description
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
Why the product was recalled
CGMP Deviations:Noted during FDA inspection
Distribution information
Distributed Nationwide in the USA
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: not stated.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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