CLASS II ONGOING Drug recall · Reported 15 Jul 2026 · FDA Enforcement Report

Azacitidine for Injection 100mg/Vial-Dose Vial recalled

Reliance Life Sciences Private is recalling Azacitidine for Injection 100mg/Vial-Dose Vial per, For Subcutaneous and Intravenous Use, distributed nationwide in the US. The recall was initiated on 24 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot, 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

Quantity recalled8,001 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0674-2026
FDA event ID: 99312
Recalling firm: Reliance Life Sciences Private, Navi Mumbai, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jun 2026
FDA classified: 8 Jul 2026
Reported: 15 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

24 Jun 2026	Recall initiated by company
8 Jul 2026	Classified by FDA	+14 days
15 Jul 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Sterility Assurance

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Lack of Sterility Assurance

Which lots are affected?

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

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 99312

This product is part of a recall event; the main page for the event is Pemetrexed for Injection 500mg/Vial-Dose Vial recalled.

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026	CLASS II	Pemetrexed for Injection 500mg/Vial-Dose Vial recalled	Reliance Life Sciences Private	Sterility	Nationwide
15 Jul 2026	CLASS II	Bortezomib for Injection 3.5mg/Vial per Single-Dose Vial recalled	Reliance Life Sciences Private	Sterility	Nationwide
15 Jul 2026	CLASS II	Pemetrexed for Injection 100mg/Vial-Dose Vial recalled	Reliance Life Sciences Private	Sterility	Nationwide

More recalls from Reliance Life Sciences Private

All 4

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Drug	CLASS II	Pemetrexed for Injection 100mg/Vial-Dose Vial recalled	Reliance Life Sciences Private	Sterility	Nationwide
15 Jul 2026Drug	CLASS II	Bortezomib for Injection 3.5mg/Vial per Single-Dose Vial recalled	Reliance Life Sciences Private	Sterility	Nationwide
15 Jul 2026Drug	CLASS II	Pemetrexed for Injection 500mg/Vial-Dose Vial recalled	Reliance Life Sciences Private	Sterility	Nationwide

Other Azacitidine recalls

All 9

Reported	Class	Recall	Company	Reason	Where
24 Aug 2022Drug	CLASS III	Azacitidine for Injection, 100 mg Lyophilized Powder recalled	Amerisource Health Services	Potency & Assay	Nationwide
17 Aug 2022Drug	CLASS III	Azacitidine for Injection 100mg/vial Lyophilized Powder recalledAzacitidine	Teva Pharmaceuticals USA	Potency & Assay	OH
2 Mar 2022Drug	CLASS III	Azacitidine, 100mg/vial, One Single-dose Vial recalledAzacitidine	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
2 Mar 2022Drug	CLASS III	Azacitidine, 1,00mg/Vial, One Single-dose Vial recalledAzacitidine	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
23 Dec 2020Drug	CLASS II	Azacitidine for Injection 100 mg/vial For Subcutaneous recalled by CIPLA	Cipla	Sterility	Nationwide