Class II · Moderate risk
Pemrydi Rtu
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Pemrydi Rtu (Pemetrexed Disodium)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
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
Affected NDC
70121-2453-01
Compare with the code on your package — it is the most precise check available.
Drug: Pemetrexed
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Pemrydi Rtu Pemetrexed disodium NDC 70121-2453 |
HEMIPENTAHYDRATE 100 mg/10mL | Injection Intravenous |
Amneal Pharmaceuticals LLC | Rx |
- Recalling firm
- Shilpa Medicare Limited
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0764-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Pemetrexed recalls
See all
Class II · Moderate risk
Pemetrexed for Injection 500mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Pemetrexed for Injection 100mg/Vial
Lack of Sterility Assurance
Class II · Moderate risk
Pemetrexed 910 Mg Qs 100 Ml Ns Ivpb
Lack of Assurance of Sterility
Other recalls by Shilpa Medicare Limited
All 2026 recalls
Class II · Moderate risk
Pemrydi Rtu
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Class II · Moderate risk
Docetaxel Injection USP 160 mg/8mL
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablets 400 mg
CGMP Deviations
Class II · Moderate risk
Imatinib Mesylate Tablets 100 mg
CGMP Deviations
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