Albuterol inhalers recalled after failing stability specification for particle size distribution
Cipla Albuterol Sulfate Inhalation Aerosol, 90 mcg, lot 4IB0519, is recalled nationwide after out-of-specification particle size distribution results at the 12-month stability point. 20,352 packs are affected.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The rubric puts FDA Class III actions at 1 or 2, and this is a stability test result outside specification with no health consequence described in the notice.
Plain-English summary
Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 metered inhalations, net content 6.7 g, is being recalled. The product is manufactured by Cipla Ltd in Indore, Pithampur, India for Cipla USA, Inc. of Warren, New Jersey. The affected product is lot 4IB0519 with an expiry of 04/30/2026, and the recall covers 20,352 packs distributed nationwide.
The recall was issued because the product failed stability specifications: out-of-specification results were observed in the induction port during analysis of particle size distribution at the 12-month time point. The FDA classified the action as Class III.
Patients should check the lot number on their inhaler against the recall and should speak to their pharmacist or prescriber about a replacement before stopping use of a prescribed inhaler.
The recalled product
- Product
- ALBUTEROL SULFATE (ALBUTEROL SULFATE)
- Brand
- ALBUTEROL SULFATE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Respiratory
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 4IB0519
- Exp. 04/30/2026
Distribution
Distributed nationwide across the United States.
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