CLASS II Drug recall · Reported 16 Dec 2020 · FDA Enforcement Report

Azacitidine for Injection 100 mg/vial, For Subcutaneous recalled

Shilpa Medicare is recalling Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, distributed nationwide in the US. The recall was initiated on 8 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s: 7S10115A, Exp. 07/31/2021; 7S10143A, 7S10182B, Exp. 09/30/2021; 7S10255A, 7S10256A, 7S10263A, Exp. 11/30/2021; 7T10028A, 12/31/2021; 7T10040A, Exp. 01/31/2022.

NDC72485-201

UPC0372485201013

Quantity recalled35,931 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-0122-2021
FDA event ID: 86749
Recalling firm: Shilpa Medicare, Polepally, Jadcherla, N/A
Brand: Azacitidine
Manufacturer: Armas Pharmaceuticals Inc.
Classification: Class II
Status: Terminated
Recall initiated: 8 Dec 2020
FDA classified: 9 Dec 2020
Reported: 16 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations
Drug class: Injectable & IV Drugs

Timeline

8 Dec 2020	Recall initiated by company
9 Dec 2020	Classified by FDA	+1 day
16 Dec 2020	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

CGMP Deviations

Product as listed by the FDA

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Distributed by: Armas Pharmaceuticals, Inc. Manalapan, NJ 07726 NDC 72485-201-01.

Where it was distributed

Nationwide in the U.S.

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations

Which lots are affected?

Lot #s: 7S10115A, Exp. 07/31/2021; 7S10143A, 7S10182B, Exp. 09/30/2021; 7S10255A, 7S10256A, 7S10263A, Exp. 11/30/2021; 7T10028A, 12/31/2021; 7T10040A, Exp. 01/31/2022.

Where was it sold?

Nationwide in the U.S.

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 21 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

5 other products · FDA event 86749

Reported	Class	Recall	Company	Reason	Where
16 Dec 2020	CLASS II	Imatinib Mesylate Tablets 400 mg recalled by Shilpa MedicareImatinib Mesylate	Shilpa Medicare	Manufacturing (CGMP) Deviations	Nationwide
16 Dec 2020	CLASS II	Azacitidine for Injection 100 mg/vial, For Subcutaneous recalled	Shilpa Medicare	Manufacturing (CGMP) Deviations	Nationwide
16 Dec 2020	CLASS II	Docetaxel Injection USP 160 mg/ (20 mg/mL) recalled by Shilpa Medicare	Shilpa Medicare	Manufacturing (CGMP) Deviations	Nationwide
16 Dec 2020	CLASS II	Busulfan Injection 60 mg/ (6 mg/mL) recalled by Shilpa Medicare	Shilpa Medicare	Sterility	Nationwide
16 Dec 2020	CLASS II	Imatinib Mesylate Tablets 100 mg recalled by Shilpa MedicareImatinib Mesylate	Shilpa Medicare	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Shilpa Medicare

All 8

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Pemrydi RTU(pemetrexed injection), 500 mg/ (10 mg/mL) recalledPemrydi Rtu	Shilpa Medicare	Other	Nationwide
26 Aug 2026Drug	CLASS II	Pemrydi RTU (pemetrexed injection), 100 mg/ (10 mg/mL) recalledPemrydi Rtu	Shilpa Medicare	Other	Nationwide
16 Dec 2020Drug	CLASS II	Imatinib Mesylate Tablets 100 mg recalled by Shilpa MedicareImatinib Mesylate	Shilpa Medicare	Manufacturing (CGMP) Deviations	Nationwide
16 Dec 2020Drug	CLASS II	Busulfan Injection 60 mg/ (6 mg/mL) recalled by Shilpa Medicare	Shilpa Medicare	Sterility	Nationwide
16 Dec 2020Drug	CLASS II	Docetaxel Injection USP 160 mg/ (20 mg/mL) recalled by Shilpa Medicare	Shilpa Medicare	Manufacturing (CGMP) Deviations	Nationwide

Other Azacitidine recalls

All 8

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