FlaggedRx← Medication recall checkHome
Class III · Lower riskActive recall

Albuterol Sulfate

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot#: 4IB0519, Exp. 04/30/2026
Where it was soldU.S. Nationwide.
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

Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.

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, SEZ, 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 Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.
Recalling firmCipla USA, Inc.
DistributionU.S. Nationwide.
Quantity20352 packs (1x 200 MD)
Recall initiated2025-07-24
Report date2025-08-27
Recall completed—
Recall numberD-0593-2025
ClassificationClass III
FDA statusOngoing
Origin on fileWarren NJ United States

Related

Albuterol recallsRecent drug recallsCheck another medication

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.