RECALL DATABASE

Reliance Life Sciences Private Limited Pemetrexed for Injection 100mg Recall

Announced 2026-07-15 · FDA

FDA is recalling Reliance Life Sciences Private Limited's Pemetrexed for Injection due to lack of sterility assurance. Approximately 12,000 vials were distributed nationwide in the United States. The recall covers multiple lots with expiry dates; no corrective action is provided in the notice.

BrandReliance Life Sciences Private Limited
ProductPemetrexed 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
ReasonLack of Sterility Assurance
Severitymoderate
Units affected5020
DistributionNationwide in the USA
AgencyFDA
Recall / campaign no.Lot, expiry: RPTL0325A Dec 31, 2027; RPTL0425A Dec 31, 2027; RPTL0624B Nov 30,2027; RPTL0625A Mar 31, 2028

WHAT YOU SHOULD DO

  1. Do not use recalled pemetrexed vials.
  2. Check if your vial's lot number is among recalled lots; if so, contact your supplier or healthcare provider for replacement or return instructions.
  3. If you have used the product or have questions, contact your healthcare provider or pharmacist for guidance.
  4. Follow disposal instructions from FDA or your healthcare provider if advised to discard.

This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.