PEMRYDI RTU recall (Shilpa Medicare Limited)
DrugClass IIOngoing
Summary: Shilpa Medicare Limited is recalling 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.
What is being recalled
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
Why
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA.
How to tell if yours is affected
Lot: P400172; Lot PA00050A, Exp 09/30/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0764-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 29, 2026 |
| Reported | August 26, 2026 |
| Company | Shilpa Medicare Limited |
| Company location | Jadcherla, Mahabubnagar District, India |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 18,434 10mL vials |
More recalls from Shilpa Medicare Limited · all drug recalls · recalls from July 2026