Class III Recall of Albuterol Sulfate Inhalation Aerosol

Cipla USA, Inc. has voluntarily initiated a Class III recall of its Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 metered inhalations, 6.7 g canisters) following quality concerns identified during routine testing. The product was manufactured by Cipla Ltd in India and distributed nationwide across the United States. According to the US Food & Drug Administration (FDA) Enforcement Report, the recall affects 20 352 packs from lot number 4IB0519 with an expiration date of April 30, 2026. No press release has been issued, but notifications were sent to distributors and health care providers via letter.

The recall was prompted by stability testing failures. Specifically, results showed the product did not meet specifications for particle size distribution at the 12-month testing mark, with out-of-specification findings observed in the induction port. The recall was classified as Class III by the FDA, which indicates that use of or exposure to the recalled product is unlikely to cause adverse health consequences. Still, the company is removing the affected lot from circulation out of precaution while the issue is under investigation.

Albuterol sulfate inhalation aerosol is a short-acting beta2-adrenergic agonist (SABA) commonly prescribed for the treatment and prevention of bronchospasm in patients with reversible obstructive airway diseases such as asthma and chronic obstructive pulmonary disease (COPD). It is also used for the prevention of exercise-induced bronchospasm. Pharmacists should be aware of this recall when dispensing albuterol products and check inventory to ensure the affected lot is properly removed from stock.