FDAsafety guidance66% confidence
Sun Pharmaceutical Industries, Inc. (Sun Pharma) Initiates Voluntary U.S.
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ophthalmology) as THEA PHARMA; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
FOR IMMEDIATE RELEASE MUMBAI, INDIA and PRINCETON, NJ - May 13, 2026 – Sun Pharma is voluntarily recalling within the U.S. to the hospital/user level, one batch of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL, Lot # HAG2581B, Expiration 05/2027 (675 vials).
Supporting Context
- Therapeutic area
- Ophthalmology · Glaucoma
- Sub-indication
- Ophthalmology
Related signal: FDA Accepts Application for COSOPT PF Supplement by THEA PHARMA