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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

CIPLA: Azacitidine for Injection Recalled Due to Potential Sterility Risk

Agency Publication Date: December 16, 2020
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Summary

Approximately 2,151 vials of Azacitidine for Injection (100 mg/vial), a medication used for subcutaneous and intravenous treatment, have been recalled because the vials may not have been sealed correctly. This manufacturing defect could compromise the sterility of the drug, which is critical for injectable medications. Consumers and healthcare providers should check for specific lot number 7S10182A with an expiration date of September 2021.

Risk

A compromised vial seal can allow bacteria or other contaminants to enter the medication. Injecting a non-sterile drug directly into the body poses a significant risk of serious infection or other adverse health complications.

What You Should Do

  1. Check your medication supply for Azacitidine for Injection 100 mg/vial (NDC 69097-805-40).
  2. Verify the lot number and expiration date on the vial label or packaging; look specifically for Lot 7S10182A with an expiration date of 9/2021.
  3. If you have an affected vial, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a safe replacement.
  4. Return any unused product from the affected lot to the pharmacy or place of purchase for a refund.
  5. Contact the manufacturer, CIPLA, or the distributor at 10 Independence Blvd, Warren, New Jersey for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Azacitidine for Injection (100 mg/vial)
Model:
NDC 69097-805-40
Recall #: D-0165-2021
Lot Numbers:
7S10182A (Exp 9/2021)
Date Ranges: September 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86969
Status: Resolved
Manufacturer: CIPLA
Manufactured In: India, United States
Units Affected: 2151 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.