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Medium risk Drugs & MedicationsClass II

Shoolin Pharma Sildenafil Citrate Recall

SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 4

Updated August 3, 2026

Shoolin Pharma Chem LLP has recalled a bulk sildenafil citrate powder used for prescription compounding due to manufacturing process deviations found during FDA inspection. Pharmacies and compounders should stop using this ingredient and obtain replacement stock to ensure patient safety.

Is the Shoolin Pharma Chem LLP recalled? Yes. This product was recalled by FDA on August 3, 2026. Details below.

What is recalled

Sildenafil Citrate USP, 100 gram bags (0.100 kg net weight), prescription compounding ingredient only, manufactured by Shoolin Pharma Chem LLP, Block/Survey no. 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat 382715, India. NDC: 85702-001-05. CAS number: 171599-83-0.

Am I affected

You are affected if you are a licensed pharmacy or compounding facility that purchased sildenafil citrate powder (100 gram bags, NDC 85702-001-05) from Shoolin Pharma Chem LLP for use in compounding prescription medications.

What to do right now

If you are a pharmacy or compounding facility, stop using this sildenafil citrate powder immediately and contact your supplier or the FDA for guidance on obtaining replacement stock that meets manufacturing standards.

The hazard

CGMP Deviations:Noted during FDA inspection

Brands affected

Shoolin Pharma Chem LLP
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0759-2026
Classification
Class II
Recalled
August 3, 2026
Read the official notice

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