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Glenmark, Sun Pharma, and Zydus have initiated drug recalls in the US due to manufacturing non-compliance. Glenmark recalled over 25 products, Sun Pharma recalled 13,700 Gabapentin bottles, and Zydus recalled 3,144 Chlorpromazine bottles.
Leading Indian pharmaceutical companies Glenmark, Sun Pharma, and Zydus have voluntarily recalled several batches of medicines from the US market due to compliance concerns. These recalls were flagged under the latest enforcement reports issued by the US Food and Drug Administration (USFDA) and are related to deviations from Current Good Manufacturing Practice (CGMP) norms and contamination risks.
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Glenmark Recall: Over 25 products withdrawn, including Propafenone, Solifenacin, Voriconazole, and Lacosamide tablets.
Sun Pharma Action: Around 13,700 bottles of Gabapentin capsules recalled due to contamination concerns.
Zydus Withdrawal: 3,144 bottles of Chlorpromazine tablets pulled from shelves due to presence of harmful impurities.
Recall Classifications: Glenmark and Zydus recalls are classified as Class II, while Sun Pharma’s is listed as Class III.
Recall Initiation Dates: Glenmark (March 13), Sun Pharma (March 4), Zydus (April 3), 2025.
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Glenmark Pharmaceuticals initiated a Class II recall of multiple products in March 2025. The action was taken due to manufacturing deviations identified by regulators. Products included in the recall list range from anti-epileptic medications to antifungals and urological drugs. These deviations, though not likely to result in severe health issues, warranted action to prevent potential reversible medical effects.
Sun Pharmaceutical Industries Inc, through its US-based unit, initiated a Class III recall of Gabapentin capsules. Approximately 13,700 bottles were withdrawn due to cross-contamination risks. The medicine is widely used for treating epilepsy and nerve-related pain. Despite the lower recall severity, such actions highlight quality assurance lapses.
Zydus Pharmaceuticals has recalled a batch of Chlorpromazine Hydrochloride Tablets after detecting levels of a harmful impurity beyond acceptable limits. These 10mg tablets are primarily prescribed for schizophrenia and mood disorders. The recall falls under Class II, indicating moderate risk.
Company | Product(s) Recalled | Recall Class | Reason for Recall | Units Affected |
Glenmark | Propafenone, Solifenacin, Voriconazole, Lacosamide, etc. | II | CGMP Deviations | 25+ Products |
Sun Pharma | Gabapentin Capsules | III | Cross-Contamination Concerns | 13,700 bottles |
Zydus | Chlorpromazine Tablets 10mg | II | Harmful Impurity Detected | 3,144 bottles |
The announcements may influence investor sentiment across pharmaceutical stocks. Despite no immediate threats to patient safety, regulatory actions often reflect lapses in operational controls. Movements in Sun Pharma share price, Glenmark share price, and Zydus share price are likely to be watched closely in response to these developments.
The recalls indicate a heightened regulatory focus on product quality and manufacturing practices. While the affected batches have been identified and pulled from the market, companies may now face intensified scrutiny and potential corrective measures across facilities supplying to regulated markets.
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