FDA Drugs recall ·

Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton… recall

Recall number
D-0672-2026
Date
(initiated June 24, 2026)
Company / brand
Reliance Life Sciences Private Limited
Ttc Area Of Midc, Navi Mumbai, N/A, India
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
5,020 vials
Hazard tags
Sterility
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

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

Why was it recalled?

Lack of Sterility Assurance

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;

Distribution

Nationwide in the USA

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0672-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.