Azacitidine recalls

Azacitidine products have been recalled 4 times, most recently on 17 Aug 2022. The recalling company is usually Dr. Reddy's Laboratories. The most common reason is potency & assay.

Total recalls4since 2020

Last 12 months0reported

Class I00% of total

Ongoing0latest 17 Aug 2022

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 0Jul 0 0

Severity split

Class I 0 0%Class II 1 25%Class III 3 75%

Why azacitidine is recalled

Potency & Assay375%
Manufacturing (CGMP) Deviations125%

Companies

Product types

Injectable & IV Drugs4100%

By year

2022375%
2020125%

All azacitidine recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
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
16 Dec 2020Drug	CLASS II	Azacitidine for Injection 100 mg/vial, For Subcutaneous recalledAzacitidine	Shilpa Medicare	Manufacturing (CGMP) Deviations	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.