Glenmark, Sun Pharma, Zydus Recall Drugs in US over Compliance Issues

    Synopsis:

    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.

    Also read: Aurobindo Pharma Gets USFDA Nod for Generic Xarelto 2.5mg Tablets

    Glenmark Pharmaceuticals

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    Key Takeaways:

    • Glenmark Recall: Over 25 products withdrawn, including Propafenone, Solifenacin, Voriconazole, and Lacosamide tablets.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.

    Also read: HAL Denies Selecting PwC for R&D Benchmarking Amid Ongoing Bids

    Glenmark Recall Overview

    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 Pharma Recall Details

    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 Approximately 13,700 bottles were withdrawn due to cross-contamination risks.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 Recall Notification

    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.

    Snapshot of Drug Recalls

    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

    Impact on Market Sentiment

    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.

    Also read: Dr Reddy’s Denies Workforce Reduction Claims Amid Cost-Cut Rumours

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    Content Partner - Dalal Street Investment Journal Wealth Advisory Private Limited



    This article is for educational purposes only and should not be considered investment advice. Market investments are subject to risks. DSIJ Wealth Advisory Private Limited is a SEBI-registered Research Analyst (Reg. No: INH000006396) and Investment Adviser (Reg. No: INA000001142). Please consult your financial adviser before investing. 

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    Publish Date: 15 Apr 2025

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