← FDA ENFORCEMENT
D-0671-2026Class II

Reliance Life Sciences Private Limited

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Reliance Life Sciences Private Limited
Product type
Drug
Status
Ongoing
Report date
2026-07-15
Distribution
Nationwide in the USA
Firm state
N/A
Product quantity
12,000 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Sterility Assurance

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →