Reported Jul 15, 2026 · Ongoing

Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx…

Reliance Life Sciences Private Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Reliance Life Sciences Private Limited · Ttc Area Of Midc · Navi Mumbai, N/A · N/A

Is this the product you have?

  • Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only
  • Manufactured forSomerset Therapeutics, LLC., Somerset
  • NJ 08873 NDC70069-0857-01
Lot codes and dates

12 of 12 products

Products covered by this recall
#Product as published
1RAZM0425A Jun 30, 2027
2RAZM0525A Jun 30, 2027
3RAZM0725A Jun 30, 2027
4RAZM0825A Jun 30, 2027
5RAZM0925A Jul 31, 2027
6RAZM1125A Jul 31, 2027
7RAZM1225A Jul 31, 2027
8RAZM1425A Jul 31, 2027
9RAZM1525A Jul 31, 2027
10RAZM1625A Aug 31, 2027
11RAZM1725A Aug 31, 2027
12RAZM2025A Sep 30, 2027
Amount recalled
8,001 vials

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

Lack of Sterility Assurance

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.