Medications & Supplements/Prescription Drugs

Cipla Albuterol Sulfate Inhalation Aerosol Recalled for Stability Failure

Agency Publication Date: August 20, 2025

Summary

Cipla USA, Inc. is recalling 20,352 packs of Albuterol Sulfate Inhalation Aerosol (90 mcg, 200 metered inhalations) due to failed stability specifications. Testing at the 12-month mark showed that the medication particles were not the correct size, which could affect how the drug is delivered to the lungs. If you use this medication and have health concerns, you should contact your healthcare provider or pharmacist for guidance.

Risk

The recall is due to "out of specification" results for particle size distribution. This means the inhaler may not deliver the consistent dose of medication required to treat respiratory symptoms effectively.

What You Should Do

The recalled product is Cipla Albuterol Sulfate Inhalation Aerosol (90 mcg, 200 metered inhalations) with NDC 69097-142-60 and lot number 4IB0519 (Expiration: 04/30/2026).
Check the NDC number and lot number printed on the inhaler canister or the outer carton to determine if your medication is part of the recall.
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.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 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

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: Albuterol Sulfate Inhalation Aerosol (6.7 g)

Variants: 90 mcg, 200 metered Inhalations

Lot Numbers:

4IB0519 (Exp. 04/30/2026)

NDC:

69097-142-60

Recall # D-0593-2025; Manufactured by Cipla Ltd, Indore, India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97304

Status: Active

Manufacturer: Cipla USA, Inc.

Sold By: Pharmacies

Manufactured In: India

Units Affected: 20352 packs (1x 200 MD)

Distributed To: Nationwide

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 · 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.

Summary

What You Should Do

The recalled product is Cipla Albuterol Sulfate Inhalation Aerosol (90 mcg, 200 metered inhalations) with NDC 69097-142-60 and lot number 4IB0519 (Expiration: 04/30/2026).

Check the NDC number and lot number printed on the inhaler canister or the outer carton to determine if your medication is part of the recall.

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.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.