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FDA · Drugs ·

TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag recall

Shoolin Pharma Chem LLP recalled TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag on August 19, 2026 because of cGMP Deviations:Noted during FDA inspection. It was sold nationwide.

Why it was recalled

CGMP Deviations:Noted during FDA inspection

What's recalled

TADALAFIL USP, 1.00 KG, 1KG(1000gm)-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 171596-29-5), NDC 85702-001-08

Quantity: 1KG - 20 X 1KG(1000gm) bags

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Shoolin Pharma Chem LLP, Kadi
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Distributed Nationwide in the USA
Status
Ongoing
Recall number
D-0762-2026
Source
U.S. Food and Drug Administration

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