drugs MODERATE Updated 2026-08-19

Shoolin Pharma Chem LLP recalls TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Pre

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Recalled Product

TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 1715996-29-5), NDC 85702-002-02.

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Hazard / Issue

CGMP Deviations:Noted during FDA inspection

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: TLF2506001, Date of Expiry: May 31, 2028.

✅ 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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