Several Indian pharmaceutical giants are pulling back batches of key medicines from the U.S. market after safety lapses and manufacturing issues were flagged by the U.S. Food and Drug Administration (USFDA). Among those named are Glenmark Pharmaceuticals, Alembic Pharmaceuticals, and Sun Pharma, all of which are recalling products under Class II recall, indicating potential but not life-threatening health risks.
Glenmark’s Double Recall of Carvedilol
Mumbai-based Glenmark Pharmaceuticals has initiated a large-scale recall through its U.S. arm, Glenmark Pharmaceuticals Inc., New Jersey.
- Carvedilol Tablets Recall: Used to treat heart failure, hypertension, and post-heart attack conditions, the recall affects 55,560 units of Carvedilol tablets due to the presence of nitrosamine impurity (N-Nitroso Carvedilol) above permissible intake levels.
- Additional Lot Recalled: Another 17,496 bottles of Carvedilol tablets were withdrawn after impurity levels exceeded the FDA’s recommended threshold of not more than 4.0 ppm.
- Theophylline Recall: Glenmark is also recalling 22,656 bottles of Theophylline extended-release tablets (400 mg), used for asthma and lung disease, because of failed dissolution tests, which raise concerns about the drug’s effectiveness.
The company commenced these Class II recalls in August 2025.
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Alembic Pharmaceuticals and Insomnia Drug Recall
Alembic Pharmaceuticals, another Gujarat-based pharma leader, has withdrawn 9,492 bottles of Doxepin Hydrochloride capsules, prescribed for insomnia treatment. The recall, initiated on July 25, 2025, was due to the detection of nitrosamine-related impurities above the provisional safety limit. Nitrosamines are known carcinogens, and regulators have become increasingly strict about their presence in medicines.
Sun Pharma and Contamination in Blood Pressure Drug
Sun Pharmaceutical Industries’ U.S. subsidiary, based in New Jersey, is recalling 11,328 bottles of Spironolactone tablets, commonly prescribed for high blood pressure and heart failure. The recall stems from the detection of a foreign contaminant identified as aluminum, raising concerns about contamination during the manufacturing process.
The company began this recall on August 5, 2025.
What Class II Recall Means
According to the USFDA, a Class II recall is issued when the use of a defective drug may cause temporary or medically reversible health problems, but the chances of serious or permanent harm are minimal. While not the most severe category (Class I recalls involve life-threatening risks), such repeated quality lapses raise questions about manufacturing practices.
Larger Implications for Indian Pharma
India is one of the largest suppliers of generic medicines to the United States, with over 40% of U.S. generics coming from Indian firms. While recalls are not unusual in the industry, the simultaneous withdrawal of products by multiple major companies underscores ongoing regulatory scrutiny of Indian pharmaceutical manufacturing standards.
With nitrosamine impurities and contamination repeatedly surfacing in recalls, experts warn that drug makers will need to strengthen quality control, supply chain monitoring, and compliance with international standards to retain their credibility in the world’s most lucrative pharma market.