Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactur
Summary
The FDA issued a Class II for Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For in by Reliance Life Sciences Private Limited. Reason: Lack of Sterility Assurance.
Details
Source
Drug Recall
External ID
D-0672-2026
Action Date
2026-07-15
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;
Quantity Affected: 5,020 vials
Reason for Recall
Lack of Sterility Assurance
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-24
Company
Navi Mumbai, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 44 drug recalls issued in the same week, part of 93 drug-related FDA actions this month.
Reliance Life Sciences Private Limited has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Reliance Life Sciences Private Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Reliance Life Sciences Private Limited have FDA actions?
Reliance Life Sciences Private Limited has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0672-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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