FDAFDA recall D-0762-2026 · Aug 19, 2026
Shoolin Pharma Chem LLP: TADALAFIL USP recall
Recall found
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
Reason for recall
CGMP Deviations:Noted during FDA inspection
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Batch TLF2506001, Date of Expiry: May 31, 2028.
- Quantity
- 1KG - 20 X 1KG(1000gm) bags
- Distribution
- Distributed Nationwide in the USA
- Recalling firm
- Shoolin Pharma Chem LLP, Kadi
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-03
Source: openFDA enforcement record D-0762-2026 · search recall number D-0762-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.