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

FDA recall notice · announced July 15, 2026 · Reliance Life Sciences Private Limited

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Lack of Sterility Assurance

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;
Quantity: 5,020 vials
Status: Ongoing
Products in this recall event:
- Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01 (D-0673-2026)
- 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 (D-0671-2026)
- Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0 (D-0674-2026)
- 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 (D-0672-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.