FDAClass IIAugust 19, 2026

Tadalafil USP recall: CGMP Deviations

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…

Why was Tadalafil USP recalled?

CGMP Deviations:Noted during FDA inspection

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
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…
Recalling firm
Shoolin Pharma Chem LLP
Quantity
1KG - 20 X 1KG(1000gm) bags
Distribution
Distributed Nationwide in the USA
Recall date
August 19, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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