Cipla has made a voluntary nationwide recall of six batches of its inhaler Albuterol Sulfate, 200 metered inhalation recall due to container defect by Cipla USA, a wholly-owned arm of the company.

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The recalled batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation), were manufactured in November 2021 with an expiry date of November 2023.

The recall was made post a market complaint on one of the inhalers, where leakage was observed through the inhaler valve.

“Out of an abundance of precaution, the 6 batches manufactured using the same lot of valves are being recalled,” the company said in a statement.

Albuterol Sulfate Inhalation Aerosol is used for the treatment and prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Cipla said that the company is notifying its distributors and customers as well as arranging for return and replacement of all recalled products.

The drug was manufactured at Cipla's Indore Unit. Albuterol is around 15 percent of US revenue and close to 3 percent of financial year 2023's sales. Albuterol's market share has reduced to 10 percent from 16 percent over the last one year.

Cipla's Indore unit has also been under the regulatory lens. The unit was inspected by the USFDA in February 2023, which issued eight observations for the same.

Brokerage firm Antique said that the recall is likely to result in a higher probability of a warning letter for the unit. Antique has a sell recommendation on Cipla.

Cipla's shares had fallen as much as 2 percent before a recovery from the lows. The stock is little changed at Rs 1,019.35.