FDA Drug · D-0760-2026

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.

Class II · Ongoing

CGMP Deviations:Noted during FDA inspection

Affected lots / codes — check yours against thisLot: TLF2506001, Date of Expiry: May 31, 2028.

Recalling firm: Shoolin Pharma Chem LLP, Kadi,
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 1KG - 100-0.1KG(100gm) bags
Distribution: Distributed Nationwide in the USA
Recall initiated: August 3, 2026
Classified: August 13, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0760-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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