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 shown green to dark green discoloration. The manufacturer received complaints from the field about affected vials. The discoloration may indicate a quality or sterility concern.
- If you have vials from Lot P400157 (expiration 08/31/2026) or Lot PA00047A (expiration 09/30/2027), do not use them.
- Contact your pharmacy or healthcare provider if you have received any affected vials.
- Return discolored vials to your pharmacy or distributor.
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
9,489 50mL 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), 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0765-2026More Shilpa Medicare recalls
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