Why it was recalled
CGMP Deviations:Noted during FDA inspection
Product description
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.
Lot numbers, UPCs & expiration codes
Lot: TLF2506001, Date of Expiry: May 31, 2028.
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0760-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 3, 2026
- FDA report date
- Aug 19, 2026
- Quantity
- 1KG - 100-0.1KG(100gm) bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Shoolin Pharma Chem LLP
Original FDA data
Every field from FDA enforcement report D-0760-2026, exactly as published.
Show all FDA fields
- City
- Kadi
- Status
- Ongoing
- Country
- India
- Event ID
- 99547
- Address
- 408 B/H Ratnamani Tubes
- Address (line 2)
- Block/Survey No; Nr Maruti Inox
- Code information
- Lot: TLF2506001, Date of Expiry: May 31, 2028.
- Report date
- Aug 19, 2026
- Product type
- Drugs
- Recall number
- D-0760-2026
- Classification
- Class II
- Recalling firm
- Shoolin Pharma Chem LLP
- Product quantity
- 1KG - 100-0.1KG(100gm) bags
- Reason for recall
- CGMP Deviations:Noted during FDA inspection
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Aug 3, 2026
- Center classification date
- Aug 13, 2026