Recall
FDAHealthJune 24, 2026

Reliance Life Sciences Private Limited — Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., So

⚠️ Lack of Sterility Assurance

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
June 24, 2026

Nationwide in the USA

What's affected?

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

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 12,000 vials.

View original FDA notice →

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