Recall archive / FDA drug enforcement

Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufact... — FDA record D-0672-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 24, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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
Reason: Lack of Sterility Assurance
Classification: Class II
Recalling firm: Reliance Life Sciences Private Limited
Quantity: 5,020 vials
Agency-reported status: Ongoing
Source record identifier: D-0672-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the USA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jul 15, 2026
Recall initiation date: Jun 24, 2026
Center classification date: Jul 8, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.