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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 Ipratropium and Albuterol Inhalation Solution Recalled for Short Fill

Agency Publication Date: April 24, 2024
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Summary

Cipla USA, Inc. is recalling 59,244 packs of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP (0.5 mg & 3mg/3mL). The recall was initiated because some vials (respules) were found to have less liquid than required, and drops of liquid were observed inside the intact sealed pouches. This prescription medication is used to treat respiratory conditions, and a short-filled vial may not provide the full prescribed dose.

Risk

A vial with less medication than intended could result in a patient receiving an insufficient dose to treat their respiratory symptoms. Additionally, liquid leaking into the pouch indicates the container may not be properly sealed, which could affect the sterility or stability of the medication.

What You Should Do

  1. This recall affects Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP (0.5 mg & 3mg/3mL) unit-dose vials, packaged in cartons containing 30 vials (NDC 69097-173-53).
  2. Identify if your medication is affected by checking the lot number and expiration date on the carton or pouch for lot IA30390 (Exp 4/30/2025) or lot IA30517 (Exp 6/30/2025).
  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. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP (3mL)
Variants: 0.5 mg & 3mg/3mL unit-dose vials, Carton of 30 vials (6 pouches of 5 vials)
Lot Numbers:
IA30390 (Exp 4/30/2025)
IA30517 (Exp 6/30/2025)
NDC:
69097-173-53

Manufactured for Cipla USA, Inc. by Cipla Ltd., Indore SEZ, Pithampur, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94289
Status: Resolved
Manufacturer: Cipla USA, Inc.
Sold By: Retail Pharmacies; Hospitals
Manufactured In: India
Units Affected: 59244/3ml FFS packs
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.