Pemetrexed for Injection Recalled Due to Lack of Sterility Assurance
Somerset Therapeutics is recalling Pemetrexed for Injection 100mg/Vial due to lack of sterility assurance. The recall affects approximately 12,000 vials distributed nationwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug. Loss of sterility assurance in an intravenous cancer medication poses serious risk of infection and other adverse health consequences; Class II recalls with such hazards are classified as Severe per the rubric.
Plain-English summary
Somerset Therapeutics, LLC is recalling Pemetrexed for Injection 100mg/Vial (NDC: 70069-0834-01), manufactured by Reliance Life Sciences Private Limited, due to lack of sterility assurance. The product is a 10 mL single-dose vial for intravenous use only.
Four affected lots have been identified: RPTL0325A (expiration Dec 31, 2027), RPTL0425A (expiration Dec 31, 2027), RPTL0624B (expiration Nov 30, 2027), and RPTL0625A (expiration Mar 31, 2028). Approximately 12,000 vials have been distributed nationwide.
Pemetrexed is an intravenous cancer medication. Lack of sterility assurance means the product may not meet required sterile manufacturing standards, potentially creating a risk of microbial contamination.
Healthcare providers who have distributed or administered this medication should contact patients and healthcare providers in their supply chain. Patients should consult their healthcare provider if they have received this product.
The recalled product
- 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
- Manufacturer
- Reliance Life Sciences Private Limited
- Category
- Drug — Injectable / Oncology
- Hazard
- sterility-assurance
- microbial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot
- expiry: RPTL0325A Dec 31
- 2027
- RPTL0425A Dec 31
- RPTL0624B Nov 30
- RPTL0625A Mar 31
- 2028
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateGasco Isopropyl Alcohol 70% recalled nationwide for subpotency
FDA (Drugs) · 2026-07-15
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- ModerateGasco Isopropyl Alcohol 70% recalled for subpotent drug content
FDA (Drugs) · 2026-07-15