FDA Drugs recall ·
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only… recall
- Recall number
- D-0761-2026
- Date
- (initiated August 3, 2026)
- Company / brand
- Shoolin Pharma Chem LLP
408 B/H Ratnamani Tubes, Kadi, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20 KG, 40 X 0.500KG(500gm) bags
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
CGMP Deviations:Noted during FDA inspection
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch TLF2506001, Date of Expiry: May 31, 2028.
Distribution
Distributed Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0761-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.