Unrated Drug recall · FDA · Published June 24, 2026

Reliance Pemetrexed Injection Recall: Lack of Sterility Risk

Reliance Life Sciences recalls Pemetrexed for Injection 500mg/vial due to lack of sterility assurance. This medication is for IV use only with a prescription. Affected lots expire Jan 2028.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0672-2026Drug Reliance Life Sciences ›

Recall notice

Lack of Sterility Assurance

Take action

Contact the company

Recalling firmReliance Life Sciences Private LimitedTtc Area Of Midc, R - 282 Dhirubhai Ambani Life Sciences Centre; Thane Belapur Road · Navi Mumbai, India

✎ GovInfoNow plain-language explainer

Reliance Life Sciences is recalling Pemetrexed for Injection 500mg/vial because it may not be sterile. This could lead to infections if used improperly. Patients should not use the recalled product without contacting their doctor. Read more at govinfonow.com/recall/31187-reliance-pemetrexed-injection-recall-lack-of-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31187-reliance-pemetrexed-injection-recall-lack-of-sterility-risk · Updated August 9, 2026 · FDA enforcement record: FDA #D-0672-2026

Cite this page

“Reliance Pemetrexed Injection Recall: Lack of Sterility Risk.” GovInfoNow, updated August 9, 2026. https://govinfonow.com/recall/31187-reliance-pemetrexed-injection-recall-lack-of-sterility-risk. Based on FDA recall #D-0672-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0672-2026%22&limit=1).

The FDA announced on June 24, 2026, that Reliance Life Sciences Private Limited is recalling Pemetrexed for Injection due to a lack of sterility assurance. The firm initiated this voluntary Class II recall affecting 5,020 vials distributed nationwide.

How to tell if you have it

Brand: Reliance Life Sciences
Product: Pemetrexed for Injection 500mg/Vial
Packaging: 1 50 mL Single-Dose Vial per carton
NDC: 70069-0835-01
Lot codes: RPTH0125A, RPTH0225A, RPTH0325A, RPTH0725A
Expiry dates: Jan 31, 2028 (lots RPTH0125A, RPTH0225A, RPTH0325A); Apr 30, 2028 (lot RPTH0725A)
Quantity: 5,020 vials
Distribution: Nationwide in the USA

The hazard

The recall addresses a lack of sterility assurance in the Pemetrexed for Injection product. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show other recent recalls involving sterility risks, including the Regeneron Libtayo injection recall on July 28, 2026, and the ProRx Semaglutide Injection Recall on October 15, 2025. Additional similar product recalls include the Opdualag Injection Recall reported on October 21, 2025.

How to tell if you have this one

Check the vial label for the lot numbers RPTH0125A, RPTH0225A, RPTH0325A, or RPTH0725A. The product expires by January 31, 2028.

Brand
Reliance Life Sciences
Category
Drug

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide in the USA

Recall number	Product, codes & lots	Quantity
D-0671-2026	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; Lot, expiry: RPTL0325A Dec 31, 2027; RPTL0425A Dec 31, 2027; RPTL0624B Nov 30,2027; RPTL0625A Mar 31, 2028	12,000 vials
D-0672-2026	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; Lot, expiry: RPTH0125A Jan 31, 2028; RPTH0225A Jan 31, 2028; RPTH0325A Jan 31, 2028; RPTH0725A Apr 30, 2028;	5,020 vials
D-0673-2026	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; Lot, expiry: RBIH0125A Jan 31, 2028; RBIH0225A Feb 29, 2028; RBIH0325A Feb 29, 2028; RBIH0525A Mar 31, 2028	11,400 vials
D-0674-2026	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: 70069-0857-01; Lot, expiry: RAZM0425A Jun 30, 2027; RAZM0525A Jun 30, 2027; RAZM0725A Jun 30, 2027; RAZM0825A Jun 30, 2027; RAZM0925A Jul 31, 2027; RAZM1125A Jul 31, 2027; RAZM1225A Jul 31, 2027; RAZM1425A Jul 31, 2027; RAZM1525A Jul 31, 2027; RAZM1625A Aug 31, 2027; RAZM1725A Aug 31, 2027; RAZM2025A Sep 30, 2027	8,001 vials

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Do not use the recalled Pemetrexed injection vials if you have the specified lot numbers.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 21 days after the firm started it.

Jun 24, 2026Firm started the recall
Jul 8, 2026FDA classified it Class II
Jul 15, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31187-reliance-pemetrexed-injection-recall-lack-of-sterility-risk">Reliance Pemetrexed Injection Recall: Lack of Sterility Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0672-2026 (June 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0672-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.