Glenmark, Alembic Pharma, Sun Pharma shares slip up to 1.5% on product recalls after USFDA action

Shares of Glenmark Pharmaceuticals, Alembic Pharmaceuticals, and Sun Pharmaceutical Industries declined up to 1.5% on Tuesday, August 19, after the US Food and Drug Administration (USFDA) reported that the three companies are recalling certain products from the US market due to manufacturing issues.

Shares of Glenmark Pharma tumbled 1.4% to their day’s low of Rs 1,945, while those of Alembic Pharmaceuticals slid 0.5% to Rs 968.40. Meanwhile, the shares of Sun Pharmaceutical Industries fell by 0.8% to Rs 1,619.10 on the BSE.

According to the latest USFDA Enforcement Report, Glenmark is recalling multiple batches of Carvedilol tablets, used to treat heart failure, hypertension, and heart attacks, in the US. The recall covers 55,560 units due to the presence of a nitrosamine impurity above the permissible limit, as well as 17,496 bottles of Carvedilol tablets exceeding the FDA-recommended limit of NMT 4.0 ppm. Additionally, Glenmark is recalling 22,656 bottles of Theophylline extended-release tablets (400 mg) after the product failed dissolution specifications. The company initiated the Class II recall in August 2025.


Alembic Pharmaceuticals has also initiated a Class II recall of 9,492 bottles of Doxepin Hydrochloride capsules, used to treat insomnia. The recall, which began on July 25, was triggered by the detection of a nitrosamine drug substance-related impurity above the proposed interim limit.

Meanwhile, Sun Pharmaceutical Industries’ US arm has recalled 11,328 bottles of Spironolactone tablets, prescribed for high blood pressure, after contamination with a foreign substance identified as aluminum. The company began the Class II recall on August 5.

As per USFDA norms, a Class II recall is initiated when the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or when the risk of serious adverse health effects is considered remote.

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