Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Jun 24, 2026 (4 months ago)

Pemetrexed for Injection 500mg/Vial

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Sterility Assurance

Cause type: Sterility / contamination

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.

What was recalled

Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01

Affected NDC 70069-0835-01

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.

ProductStrengthForm & routeLabelerType
Pemetrexed
Pemetrexed disodium
NDC 70069-0835
HEPTAHYDRATE 500 mg/20mL Injection, Powder, Lyophilized, for Solution
Intravenous
Somerset Therapeutics LLC Rx
Recalling firm
Reliance Life Sciences Private Limited
Origin
N/A, India
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0672-2026 · 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

Pemrydi Rtu

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

Ongoing Failed specification Shilpa Medicare Limited D-0765-2026
Class II · Moderate risk

Pemrydi Rtu

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

Ongoing Failed specification Shilpa Medicare Limited D-0764-2026

Other recalls by Reliance Life Sciences Private Limited

All 2026 recalls