Shilpa Medicare Limited recalls PEMRYDI RTU
- Recalling company
- Shilpa Medicare Limited
- Product
- PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1
- Reason
- Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 29, 2026
- Reported
- Aug 26, 2026
- Distribution
- Nationwide in the USA.
- Status
- Ongoing
- Quantity
- 18,434 10mL vials
- Lot / codes
- Lot: P400172; Lot PA00050A, Exp 09/30/2027
- Company location
- Jadcherla, Mahabubnagar District
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0764-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0764-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.