CIPLA recalls Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa
Cipla recalls Azacitidine 100 mg vials due to potential sterility issues from improper sealing during manufacturing. Affected vials have specific lot numbers and distribution details. Consumers should contact Cipla for guidance.
Lower-risk recall
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Contact the company & request your remedy
What happened, in plain English
Cipla is recalling Azacitidine injection vials that may not seal properly, risking contamination. This could lead to infections if the medication is used without proper sterility. Read more at govinfonow.com/recall/36615-cipla-azacitidine-injection-recall-risk-of-contamination-from-improper-sealing.
Source Summary by GovInfoNow · govinfonow.com/recall/36615-cipla-azacitidine-injection-recall-risk-of-contamination-from-improper-sealing · Updated October 4, 2026 · FDA enforcement record: FDA #D-0165-2021
Cite this page
“Cipla Azacitidine Injection Recall: Risk of Contamination from Improper Sealing.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36615-cipla-azacitidine-injection-recall-risk-of-contamination-from-improper-sealing. Based on FDA recall #D-0165-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0165-2021%22&limit=1).
Why it’s dangerous
The vials may not seal correctly during manufacturing, which could allow contaminants to enter the medication. This poses a risk of infection if the vial is used without proper sterility checks.
Who’s affected
Patients using Azacitidine injections for cancer treatment in the U.S. who received vials with lot number 7S10182A (expired 9/2021) are affected. Healthcare providers administering these vials are at higher risk.
How to tell if you have this one
Check for lot number 7S10182A on the vial label, which was manufactured by Shilpa in India and distributed by Cipla USA. The product was sold with NDC 69097-805-40 and expired 9/2021.
- Brand
Cipla- Category
Drug
What to do — step by step
Check Vial Label
Look for lot number 7S10182A on the vial label to confirm if it is affected.
Contact Cipla
Reach out to Cipla USA for instructions on what to do with the vial if it matches the recall criteria.
Questions people ask
Is this product safe to use?
The recall indicates potential sterility issues, so affected vials should not be used until contacted by Cipla for guidance.
What is the lot number for this recall?
The affected lot number is 7S10182A, which expired 9/2021.
How can I get a replacement?
Contact Cipla USA directly for instructions on obtaining a replacement vial.
Contact Cipla
We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.
Subject: Recall D-0165-2021 — Cipla Cipla Hello, I own a Cipla that is covered by recall D-0165-2021 from Cipla. 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-0165-2021 (December 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0165-2021 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.