Official recall notice

FDA DrugClass IINotable

Tadalafil USP bag Recall (Aug 2026) – Shoolin Pharma Chem LLP

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.

Recall date
2026-08-19
Category
Drug
FDA class
Class II

Why it was recalled

Hazard

CGMP Deviations:Noted during FDA inspection

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Product description

CGMP Deviations:Noted during FDA inspection

Affected products

Lot: TLF2506001, Date of Expiry: May 31, 2028.

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