Why was TADALAFIL USP recalled?

Per the FDA enforcement record, the reason for recall D-0762-2026 was: CGMP Deviations:Noted during FDA inspection

Which lots of TADALAFIL USP are affected?

Distributed: Distributed Nationwide in the USA. The recall covers these lots — Batch TLF2506001, Date of Expiry: May 31, 2028.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0762-2026.

Class IIOngoing

TADALAFIL USP recall

FDA recall D-0762-2026 · initiated Aug 3, 2026

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Aug 19, 2026How we research

Shoolin Pharma Chem LLP recalled TADALAFIL USP in Aug 2026 — an FDA Class II recall (D-0762-2026) because CGMP Deviations:Noted during FDA inspection.

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations:Noted during FDA inspection

The manufacturing process itself

The FDA found the process itself out of compliance, usually before any defective product was identified.

This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.

Is your product affected? Check the lot number

A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.

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

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

Details

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 Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08
Recalling company: Shoolin Pharma Chem LLP
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Distributed Nationwide in the USA
Initiated: Aug 3, 2026
FDA report date: Aug 19, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was TADALAFIL USP recalled?: Shoolin Pharma Chem LLP recalled TADALAFIL USP in Aug 2026 — an FDA Class II recall (D-0762-2026) because CGMP Deviations:Noted during FDA inspection. May cause temporary or medically reversible harm; low probability of serious harm.
Why was TADALAFIL USP recalled?: Per the FDA enforcement record, the reason for recall D-0762-2026 was: CGMP Deviations:Noted during FDA inspection
Is a recalled TADALAFIL USP dangerous to take?: An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
Which lots of TADALAFIL USP are affected?: Distributed: Distributed Nationwide in the USA. The recall covers these lots — Batch TLF2506001, Date of Expiry: May 31, 2028.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0762-2026.

Source: openFDA Drug Enforcement record D-0762-2026 ↗

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