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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: July 22, 2025
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Summary

Cipla USA, Inc. has recalled 13,680 ampoules of Budesonide Inhalation Suspension (0.5mg/2ml), a prescription medication used for breathing conditions. The recall was triggered by a report of leaking and empty ampoules, which means the sterile seal of the medicine could be compromised. The medication is sold in cartons of 30 single-dose ampoules, with five ampoules per pouch. If you use this medication, you should consult your doctor or pharmacist regarding your treatment.

Risk

If the sterile seal of an inhalation medication is broken, the liquid can become contaminated with bacteria or other germs. Using a non-sterile product in a nebulizer can cause serious respiratory infections, especially in patients who already have weakened lungs or immune systems.

What You Should Do

  1. This recall affects Budesonide Inhalation Suspension (0.5mg/2ml) sold in 30-count cartons under NDC 69097-319-87 and in individual pouches under NDC 69097-319-86.
  2. Check your medication packaging for Batch # 4IA0505 with an expiration date of 09/31/2026.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Cipla USA, Inc. directly for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have 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 (0.5mg/2ml)
Variants: 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only
Lot Numbers:
4IA0505 (Exp 09/31/2026)
NDC:
69097-319-86
69097-319-87

Manufactured by Cipla Ltd. Indore SEZ, Pithampur, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97170
Status: Active
Manufacturer: Cipla USA, Inc.
Sold By: Pharmacies
Manufactured In: India
Units Affected: 13,680 ampoules
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.