Shilpa Medicare Limited recalls Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial,
Shilpa Medicare Limited recalls Azacitidine 100 mg/vial injections due to CGMP deviations. Affected lots expired by 2022. Contact for return instructions.
Recall notice
CGMP Deviations
Contact the company & request your remedy
What happened, in plain English
Shilpa Medicare Limited is recalling Azacitidine 100 mg/vial injections because of manufacturing quality control issues. This recall affects specific lots that expired by January 2022. Patients should not use these products as they may be unsafe. Read more at govinfonow.com/recall/36620-shilpa-medicare-azacitidine-injection-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36620-shilpa-medicare-azacitidine-injection-recall-cgmp-deviations-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0122-2021
Cite this page
“Shilpa Medicare Azacitidine Injection Recall: CGMP Deviations Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36620-shilpa-medicare-azacitidine-injection-recall-cgmp-deviations-risk. Based on FDA recall #D-0122-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0122-2021%22&limit=1).
Why it’s dangerous
CGMP deviations mean the product may not meet safety and quality standards. This could lead to potential harm if the medication is used improperly. The exact risk level isn't clearly stated in the recall notice.
Who’s affected
Patients prescribed Azacitidine injections by a doctor. Those with the specific lot numbers listed in the recall are most at risk.
How to tell if you have this one
Check the lot number on the vial label. The affected lots include 7S10115A (exp 07/31/2021), 7S10143A, 7S10182B (exp 09/30/2021), and others expiring by January 2022.
- Brand
Shilpa Medicare- Category
Drug
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the U.S.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0121-2021 | Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08.; Lot #: 7S10008B, Exp. 12/31/2020 | 2,064 vials | — |
| D-0122-2021 | 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.; 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. | 35,931 vials | 72485-201-01 |
| D-0123-2021 | 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, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.; Lot #: 7S10227A, Exp. 10/31/2021 | 6,560 vials | — |
| D-0124-2021 | Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.; Lot #s: 7S10033B, 7S10033A, 7S10031A, Exp. 02/28/2021. | 2611 bottles | 72485-202-90 |
| D-0125-2021 | Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.; Lot #s: 7S10032A, 7S10034A, Exp. 02/28/2021 | 4166 bottles | 72485-203-30 |
| D-0126-2021 | Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08.; Lot #: 7S10185A, Exp. 10/31/2021 | 2008 vials | — |
What to do — step by step
Check Lot Number
Look for the lot number on the vial label to determine if it's affected.
Questions people ask
Is this product safe to use?
The recall states there were CGMP deviations, but does not specify if the product is safe to use. Patients should not use it without consulting their doctor.
How do I know if I have the recalled product?
Check the lot number on the vial label. Affected lots include 7S10115A (exp 07/31/2021), 7S10143A, 7S10182B (exp 09/30/2021), and others expiring by January 2022.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact the manufacturer or your doctor for guidance.
Contact Shilpa Medicare
We’ve drafted a message you can send Shilpa Medicare to request your refund or repair — edit it as you like.
Subject: Recall D-0122-2021 — Shilpa Medicare Shilpa Medicare Hello, I own a Shilpa Medicare that is covered by recall D-0122-2021 from Shilpa Medicare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0122-2021 (December 8, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0122-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.