Sun Pharma, Lupin, Alkem recall products from US market

Indian companies supply 20 percent of the world’s pharma generics

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26 Aug, 2025 12:21

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Pharmaceutical products manufactured by Sun Pharma, Lupin Laboratories and Alkem Laboratories are being recalled from the US market, as per a list issued in the weekly enforcement report of the US Food and Drug Administration (USFDA).

The Mumbai-based Sun Pharmaceutical Industries is recalling 54,960 bottles of Mesalamine Extended-Release Capsules from the US. It is an anti-inflammatory medicine used to treat a type of bowel disease known as ulcerative colitis. The company is recalling the lot due to "Failed Dissolution Specifications: out of specification for dissolution.", the USFDA stated. The product was manufactured at Sun Pharma’s Mohali unit.

The Mohali facility has been under the US FDA scanner for some time. The USFDA had directed the company to take corrective actions at the Mohali facility before further releasing final product batches into the US. According to the latest quarterly updates, some issues persist.

The American drug regulator stated that Ascend Laboratories (a subsidiary of Alkem Ltd.) is recalling 71,244 units of Fosfomycin Tromethamine Granule sachets. It is an antibiotic used to treat bladder infections (such as acute cystitis or lower urinary tract infections). This product was manufactured by Alkem in India.

The company is recalling the lot due to “failed Impurities/degradation specification: out of specification for organic impurities.”

The USFDA also stated that Mumbai-based Lupin is recalling an unspecified number of Voriconazole for Oral Suspension tablets in the US.

The medication is used to treat various types of fungal infections. Baltimore-based Lupin Pharmaceuticals Inc, a unit of the company, is recalling the affected lot that was manufactured by Novel Laboratories, Inc. Somerset, USA. The company is recalling the lot due to “incorrect or missing package Insert”.

All three recalls were Class II recalls according to the USFDA. A Class II recall is where the use of, or exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote, according to the US FDA.

Communications to the companies seeking response on the matter have remained unanswered.

Indian companies supply 20 percent of the world’s pharma generics, 60 percent of global vaccines and 40 percent of the medicines in the US according to Indian Pharmaceutical Association.