Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Albuterol Sulfate Inhalation Aerosol Recalled by Cipla USA, Inc. Due to Defective container: empty inhaler and leakage observed through...

Date: June 27, 2023
Company: Cipla USA, Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cipla USA, Inc. directly.

Affected Products

Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60

Quantity: 278,538 canisters

Why Was This Recalled?

Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cipla USA, Inc.

Cipla USA, Inc. has 15 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report