Azacitidine for Injection Recall Issued by Reliance Life Sciences
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Reliance Life Sciences Private Limited is recalling Azacitidine for Injection due to lack of sterility assurance. The Class II recall affects 8,001 vials distributed nationwide in the USA.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Reliance Life Sciences Private Limited initiated a voluntary recall of Azacitidine for Injection due to lack of sterility assurance. The recall was classified as Class II by the FDA.
Which Products Are Affected
The affected product is 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. A total of 8,001 vials are involved. Affected lots include: 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). The recall number is D-0674-2026. Distribution was nationwide in the USA.
What You Should Do
Consumers and healthcare providers should stop using the affected product and contact the recalling firm for return or refund instructions. The firm initiated the recall via letter.
Why This Matters
Lack of sterility assurance in injectable drugs can pose risks of infection or adverse health consequences.
Source
FDA recall D-0674-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,278 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.