Azacitidine recalls

The FDA has published 8 recalls involving Azacitidine since 2020. The latest was reported on 15 Jul 2026. Most were for potency & assay. Shilpa Medicare has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls8since 2020

Last 12 months1reported

Class I00% of total

Ongoing1latest 15 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 1Jul 0 0

Severity split

Class I 0 0%Class II 4 50%Class III 4 50%

Why azacitidine is recalled

Companies

By year

2026113%
2022450%
2020338%

Ongoing azacitidine recalls

1 active

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Drug	CLASS II	Azacitidine for Injection 100mg/Vial-Dose Vial recalled	Reliance Life Sciences Private	Sterility	Nationwide

All azacitidine recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Drug	CLASS II	Azacitidine for Injection 100mg/Vial-Dose Vial recalled	Reliance Life Sciences Private	Sterility	Nationwide
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
16 Dec 2020Drug	CLASS II	Azacitidine for Injection 100 mg/vial, For Subcutaneous recalled	Shilpa Medicare	Manufacturing (CGMP) Deviations	Nationwide
16 Dec 2020Drug	CLASS II	Azacitidine for Injection 100 mg/vial, For Subcutaneous recalledAzacitidine	Shilpa Medicare	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Azacitidine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.