Class II · Moderate risk
Sildenafil Citrate USP
CGMP Deviations:Noted during FDA inspection
Sildenafil Citrate USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations:Noted during FDA inspection
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDC
85702-0001-05
Compare with the code on your package — it is the most precise check available.
Drug: Sildenafil
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sildenafil Citrate NDC 85702-0001 |
100 g/100g | Powder | Shoolin Pharma Chem LLP | BULK INGREDIENT |
- Recalling firm
- Shoolin Pharma Chem LLP
- NDC code
- 85702-001-05
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0759-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Sildenafil recalls
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Class II · Moderate risk
Sildenafil Tablets USP 100 mg
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Class II · Moderate risk
Sildenafil 50 mg Troche
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class II · Moderate risk
Sildenafil 80 mg capsules
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Class II · Moderate risk
Sildenafil 200 mg Troche
Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.
Other recalls by Shoolin Pharma Chem LLP
All 2026 recalls
Class II · Moderate risk
Sildenafil Citrate USP
CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk
Tadalafil USP
CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk
Tadalafil USP
CGMP Deviations:Noted during FDA inspection
Class II · Moderate risk
Tadalafil USP
CGMP Deviations:Noted during FDA inspection
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