FDA-Drug2026-08-26Class IIPROCESSING DEFECT
Shilpa Medicare PEMRYDI RTU pemetrexed injection recalled for green discoloration
What this means
Certain vials of PEMRYDI RTU (pemetrexed injection) have developed green to dark green discoloration. The affected lots are P400172 and PA00050A, expiring 09/30/2027. Discoloration may indicate a quality issue with the medication.
- Check your pharmacy supply for lots P400172 and PA00050A with expiration 09/30/2027.
- Do not use any vial showing green or dark green discoloration.
- Contact your pharmacy or healthcare provider if you have received an affected lot.
The agency's original wording
Hazard
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA.
Affected count
18,434 10mL vials
Manufactured in
Plot No. S20 to S26, Pharmaceutical Formulations SEZ, TSIIC Green Industrial Park, Polepally (Village), Jadcherla, Mahabubnagar District, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0764-2026More Shilpa Medicare recalls
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