Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus…
Shilpa Medicare Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shilpa Medicare Limited · Plot No. S20 to S26, Pharmaceutical Formulations SEZ, TSIIC Green Industrial Park, Polepally (Village) · Jadcherla, Mahabubnagar District
Is this the product you have?
- PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only
- Manufactured byZydus Lifesciences Limited, Ahmedabad, India
- Distributed byAmneal Pharmaceuticals LC, Bridgewater, NY 08807
- NDC70121-2453-1
- Lot codes and dates
- Lot
P400172Lot PA00050AExp 09/30/2027
- Lot
- Amount recalled
- 18,434 10mL vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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