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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

Budesonide Inhalation Suspension Recalled for Lack of Sterility Assurance

Agency Publication Date: September 27, 2022
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Summary

Cipla is recalling 641,160 ampules of Budesonide (budesonide) Inhalation Suspension 0.25mg/2mL due to a lack of sterility assurance. Sterility is critical for inhaled medications; if the product is contaminated, it could lead to respiratory or other systemic infections. No injuries or illnesses have been reported to date in connection with this recall.

Risk

The lack of sterility assurance means the manufacturer cannot guarantee the medication is free from bacteria or other microorganisms. Inhaling non-sterile medication directly into the lungs poses a significant risk of infection, especially for individuals with compromised immune systems or underlying respiratory conditions.

What You Should Do

  1. This recall affects Budesonide Inhalation Suspension (0.25mg/2mL) packaged in envelopes containing five 2 mL single-dose ampules.
  2. Identify affected products by checking the label for NDC 69097-318-86 and looking for lot numbers GA20080, GA20081, or GA20094 with an expiration date of 01/2024.
  3. If you have health concerns or believe you have experienced a reaction from using this product, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer, Cipla, for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Budesonide Inhalation Suspension 0.25mg/2mL
Variants: 0.25mg/2mL, Single Dose Ampules
Lot Numbers:
GA20080 (Exp. 01/2024)
GA20081 (Exp. 01/2024)
GA20094 (Exp. 01/2024)
NDC:
69097-318-86

Packaged as 1 envelope x five 2 mL ampules per pouch; Manufactured by Cipla Ltd., India for Cipla USA Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90864
Status: Resolved
Manufacturer: CIPLA
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 641,160 ampules
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.