PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifescienc
Summary
The FDA issued a Class II for PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx by Shilpa Medicare Limited. Reason: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials.
Details
Source
Drug Recall
External ID
D-0765-2026
Action Date
2026-08-26
Status
Ongoing
Category
drug
Product Description
PEMRYDI RTU(pemetrexed injection), 500 mg/50 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: 70121-2461-1
Lot/Code Info: Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027
Quantity Affected: 9,489 50mL vials
Reason for Recall
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-29
Company
Jadcherla, Mahabubnagar District
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 42 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Shilpa Medicare Limited has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Shilpa Medicare Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Shilpa Medicare Limited have FDA actions?
Shilpa Medicare Limited has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0765-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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