Class IIDrug
Pemrydi Rtu recall
Summary
Shilpa Medicare Limited is recalling PEMRYDI RTU (pemetrexed injection) (drug). According to the FDA report, the reason is: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials. 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
- 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
- Lot / code info
- Lot: P400172; Lot PA00050A, Exp 09/30/2027
- Quantity
- 18,434 10mL vials
- Distribution
- Nationwide in the USA.
- Recalling company
- Shilpa Medicare Limited, Jadcherla, Mahabubnagar District, India
- Recall started
- July 29, 2026
- FDA report date
- August 26, 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-0764-2026
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 (Shilpa Medicare Limited) 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.