Class IIDrug
Tadalafil USP recall
Summary
Shoolin Pharma Chem LLP is recalling TADALAFIL USP (drug). According to the FDA report, the reason is: CGMP Deviations:Noted during FDA inspection. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- Product
- TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-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 85702-002-04.
- Reason
- CGMP Deviations:Noted during FDA inspection
- Lot / code info
- Batch TLF2506001, Date of Expiry: May 31, 2028.
- Quantity
- 20 KG, 40 X 0.500KG(500gm) bags
- Distribution
- Distributed Nationwide in the USA
- Recalling company
- Shoolin Pharma Chem LLP, Kadi, India
- Recall started
- August 3, 2026
- FDA report date
- August 19, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0761-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Shoolin Pharma Chem LLP) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.