Recall Ledger

Pemetrexed for Injection 100mg/Vial recall (Reliance Life Sciences Private Limited)

DrugClass IIOngoing

Summary: Reliance Life Sciences Private Limited is recalling Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01. Reason: Lack of Sterility Assurance.

What is being recalled

Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01

Why

Lack of Sterility Assurance

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Nationwide in the USA

How to tell if yours is affected

Lot, expiry: RPTL0325A Dec 31, 2027; RPTL0425A Dec 31, 2027; RPTL0624B Nov 30,2027; RPTL0625A Mar 31, 2028

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0671-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJune 24, 2026
ReportedJuly 15, 2026
CompanyReliance Life Sciences Private Limited
Company locationNavi Mumbai, N/A, India
Initiated byVoluntary: Firm initiated
Quantity12,000 vials

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