Albuterol Inhalation Aerosol Recalled for Failed Stability Specifications
Cipla USA is recalling Albuterol Sulfate inhalation aerosol (90 mcg, lot 4IB0519) due to out-of-specification particle size distribution detected during 12-month stability testing. Approximately 20,352 units were distributed nationwide.
What this means for you
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: This is an FDA Class III recall with no reported illnesses or injuries. The hazard—particle size distribution out of specification—is a manufacturing quality control issue identified through proactive stability testing, with no documented patient impact.
Plain-English summary
Cipla USA, Inc. is recalling Albuterol Sulfate inhalation aerosol (90 mcg, 200 metered inhalations) due to failed stability specifications. Out-of-specification results were observed during particle size distribution analysis at the 12-month stability testing time point in the induction port.
The affected product is lot 4IB0519 with an expiration date of 04/30/2026. Approximately 20,352 packs were distributed nationwide in the United States.
Patients who have this product should contact their pharmacy or healthcare provider for guidance. Do not discard medication without specific instructions from a healthcare professional.
The recalled product
- Product
- ALBUTEROL SULFATE (ALBUTEROL SULFATE)
- Brand
- ALBUTEROL SULFATE
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Inhalation Aerosol
- Hazard
- stability-failure
- particle-size-deviation
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.
Related recalls
Same brand · ALBUTEROL SULFATE
- HighAlbuterol Sulfate Inhaler Recalled Due to Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- ModerateAlbuterol sulfate inhalation aerosol recalled for temperature storage deviation
FDA (Drugs) · 2024-01-03
- CriticalPrescription albuterol inhalers recalled nationwide due to defective valve seals
FDA (Drugs) · 2023-07-19
- HighAlbuterol Sulfate Inhalation Solution Recalled for Temperature-Related Manufacturing Deviations
FDA (Drugs) · 2022-06-15
- HighAlbuterol Sulfate Inhalation Aerosol Recalled for Temperature Abuse During Distribution
FDA (Drugs) · 2022-06-15
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27