drugs MODERATE Updated 2026-08-19

Shoolin Pharma Chem LLP recalls SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY

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Recalled 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

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Hazard / Issue

CGMP Deviations:Noted during FDA inspection

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Batch SDC2505001, Date of Expiry: April 30, 2030.

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.

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