FDAFDA recall D-0764-2026 · Aug 26, 2026
Shilpa Medicare Limited: PEMRYDI RTU (pemetrexed injection) recall
Recall found
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 for recall
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot: P400172; Lot PA00050A, Exp 09/30/2027
- Quantity
- 18,434 10mL vials
- Distribution
- Nationwide in the USA.
- Recalling firm
- Shilpa Medicare Limited, Jadcherla, Mahabubnagar District
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-29
Source: openFDA enforcement record D-0764-2026 · search recall number D-0764-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.