Stop using now Drug recall · FDA · Published June 27, 2023

Cipla Recalls Albuterol Inhalers Due to Defective Containers

Cipla USA recalls Albuterol Sulfate Inhalation Aerosol due to defective containers that may be empty or leak. Check lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0938-2023Drug Cipla USA ›

Stop using this now

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

Take action

Contact the company

Recalling firmCipla USA, Inc.10 Independence Blvd · Warren, NJ 07059-2730

✎ GovInfoNow plain-language explainer

Cipla USA, Inc. is recalling Albuterol Sulfate Inhalation Aerosol because the container defect can result in an empty inhaler or leakage. This means users might not receive their prescribed medication dose when needed. The recall covers specific lots with an expiration date of November 30, 2023. Read more at govinfonow.com/recall/33397-cipla-recalls-albuterol-inhalers-due-to-defective-containers.

Source Summary by GovInfoNow · govinfonow.com/recall/33397-cipla-recalls-albuterol-inhalers-due-to-defective-containers · Updated October 9, 2026 · FDA enforcement record: FDA #D-0938-2023

Cite this page

“Cipla Recalls Albuterol Inhalers Due to Defective Containers.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/33397-cipla-recalls-albuterol-inhalers-due-to-defective-containers. Based on FDA recall #D-0938-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0938-2023%22&limit=1).

The FDA announced on June 27, 2023, that Cipla USA, Inc. voluntarily recalled Albuterol Sulfate Inhalation Aerosol due to defective containers that may be empty or leak. The recall affects 278,538 canisters distributed nationwide.

How to tell if you have it

Brand: Cipla USA
Product: Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation
NDC: 69097-142-60
Lot codes: IB20045, IB20055, IB20056, IB20057, IB20059, IB20072
Expiration date: Nov. 30, 2023

The hazard

The inhalers may have partially missing bottom seats (gaskets), resulting in empty devices or leakage through the valve. The FDA classified this as a Class I recall.

Context

GovInfoNow's records show Cipla USA, Inc. has had 12 other recalls since March 26, 2024. Recent issues include Cinacalcet Tablets recalled on June 29, 2026, and March 16, 2026, for N-nitroso-cinacalcet risk, and Lanreotide Injection recalled on March 13, 2026, for sterility concerns. Other recent recalls of similar products include Cipla Phytonadione Injectable Emulsion (Oct. 31, 2025) and Nephron Albuterol Inhaler (March 17, 2026).

How to tell if you have this one

Check your inhaler box for NDC 69097-142-60 and lot numbers IB20045, IB20055, IB20056, IB20057, IB20059, or IB20072. The product is a 90 mcg, 200 Metered Inhalation with a net content of 6.7 g canister. Verify the expiration date is November 30, 2023.

Brand
Cipla USA
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop using the inhaler
Do not use any Albuterol Sulfate Inhalation Aerosol with the affected lot numbers as it may be empty or leaking.
Contact your pharmacy or doctor
Reach out to your healthcare provider or pharmacist to discuss alternative treatment options and how to replace the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Jun 27, 2023Firm started the recall
Jul 19, 2023Published in FDA’s Enforcement Report
Jul 21, 2023FDA classified it Class I
Mar 6, 2025FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Cipla USA recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/33397-cipla-recalls-albuterol-inhalers-due-to-defective-containers">Cipla Recalls Albuterol Inhalers Due to Defective Containers (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0938-2023 (June 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0938-2023 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.