CLASS III Drug recall · Reported 2 Mar 2022 · FDA Enforcement Report

Azacitidine, 100mg/vial, One Single-dose Vial recalled

Dr. Reddy's Laboratories is recalling Azacitidine, 100mg/vial, One Single-dose Vial, distributed nationwide in the US. The recall was initiated on 19 Jan 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot#: H200107, Exp 8/1/2023; H200154, Exp 9/1/2023; H210020, Exp 11/1/2023; H210055, Exp 12/1/2023; H210129, Exp 1/1/2024, H210288, Exp 4/1/2024.

NDC43598-465

Quantity recalled18261 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-0576-2022
FDA event ID: 89447
Recalling firm: Dr. Reddy's Laboratories, Princeton, NJ
Brand: Azacitidine
Manufacturer: Dr. Reddy's Laboratories Inc.
Classification: Class III
Status: Terminated
Recall initiated: 19 Jan 2022
FDA classified: 22 Feb 2022
Reported: 2 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Injectable & IV Drugs

Timeline

19 Jan 2022	Recall initiated by company
22 Feb 2022	Classified by FDA	+34 days
2 Mar 2022	Published in enforcement report	+8 days

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

Reason for recall

Failed stability specifications

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62

Where it was distributed

USA Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Failed stability specifications

Which lots are affected?

Lot#: H200107, Exp 8/1/2023; H200154, Exp 9/1/2023; H210020, Exp 11/1/2023; H210055, Exp 12/1/2023; H210129, Exp 1/1/2024, H210288, Exp 4/1/2024.

Where was it sold?

USA Nationwide

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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

2 other products · FDA event 89447

This product is part of a recall event; the main page for the event is Azacitidine, 1,00mg/Vial, One Single-dose Vial recalled.

Reported	Class	Recall	Company	Reason	Where
2 Mar 2022	CLASS III	Azacitidine, 1,00mg/Vial, One Single-dose Vial recalledAzacitidine	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
2 Mar 2022	CLASS III	Bortezomib, 3.5 mg/vial, Single-Dose Vial recalled	Dr. Reddy's Laboratories	Potency & Assay	Nationwide

More recalls from Dr. Reddy's Laboratories

All 165

Reported	Class	Recall	Company	Reason	Where
17 Dec 2025Drug	CLASS III	Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
15 Oct 2025Drug	CLASS II	Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
23 Jul 2025Drug	CLASS II	Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole	Dr. Reddy's Laboratories	Other	Nationwide
23 Apr 2025Drug	CLASS I	Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam	Dr. Reddy's Laboratories	Labeling Errors	Nationwide
18 Dec 2024Drug	CLASS III	Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor	Dr. Reddy's Laboratories	Potency & Assay	Nationwide

Other Azacitidine recalls

All 9

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, 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