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Class IIOngoing

Shilpa Medicare Limited recalls 2 products

Recall date · record updated Aug 26, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Shilpa Medicare Limited
Reason
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Nationwide in the USA.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99530…

Products (2)

  1. 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

    Codes/lots: Lot: P400172; Lot PA00050A, Exp 09/30/2027Quantity: 18,434 10mL vialsRecall no. D-0764-2026Class II

  2. 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

    Codes/lots: Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027Quantity: 9,489 50mL vialsRecall no. D-0765-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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