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Class I · Most seriousRecall completed

Albuterol Sulfate

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot # IB20045, IB20055, IB20056, IB20057, IB20059, IB20072, Exp Nov. 30, 2023
Where it was soldNationwide in the US
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byCipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059 foreign manufacturer
Brand nameALBUTEROL SULFATE
Generic nameALBUTEROL SULFATE
Active ingredient(s)ALBUTEROL SULFATE
Distributed by / forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059
NDC69097-142-60
Show the full FDA record
Full product labelAlbuterol 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
Recalling firmCipla USA, Inc.
DistributionNationwide in the US
Quantity278,538 canisters
Recall initiated2023-06-27
Report date2023-07-19
Recall completed2025-03-06
Recall numberD-0938-2023
ClassificationClass I
FDA statusTerminated
Origin on fileWarren NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.