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Class II · ModerateActive recall

TADALAFIL USP

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: TLF2506001, Date of Expiry: May 31, 2028.
Where it was soldDistributed Nationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations:Noted during FDA inspection

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forShoolin Pharma Chem LLP
NDC85702-002-02
Show the full FDA record
Full product labelTADALAFIL 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.
Recalling firmShoolin Pharma Chem LLP
DistributionDistributed Nationwide in the USA
Quantity1KG - 100-0.1KG(100gm) bags
Recall initiated2026-08-03
Report date2026-08-19
Recall completed—
Recall numberD-0760-2026
ClassificationClass II
FDA statusOngoing
Origin on fileKadi India

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.