Glenmark Faces Heat as 15 Lakh ADHD Drug Bottles Recalled in US Over Impurity Concerns

Shares of Glenmark Pharmaceuticals fell sharply on April 9, losing more than 6 percent to trade at Rs 1,353 apiece, after the US Food and Drug Administration (USFDA) disclosed that the Indian pharmaceutical major had voluntarily recalled 39 drug products from the US market. The majority of these recalled medications were manufactured at the company’s Pithampur facility in Madhya Pradesh, which now faces scrutiny over Good Manufacturing Practice (GMP) deviations.

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Glenmark Faces Heat as 15 Lakh ADHD Drug Bottles Recalled in US Over Impurity Concerns USFDA Confirms Voluntary Nature of Recall Amid Rising Regulatory Pressures

Glenmark shares down 6% intraday on April 9
13% drop over last five sessions amid regulatory headwinds
USFDA cites CGMP deviations, N-Nitroso impurity concerns
Recall involves nearly 15 lakh bottles of ADHD drug Atomoxetine

USFDA Confirms Voluntary Nature of Recall Amid Rising Regulatory Pressures

According to the USFDA’s enforcement report, the recall of approximately 14.76 lakh bottles of Atomoxetine Capsules—a generic version of the ADHD drug Strattera—was initiated by Glenmark on March 13, 2025, as a voluntary measure by the company. The recalled lots include multiple strengths of the drug, all produced by Glenmark Pharmaceuticals Inc., USA, the wholly owned subsidiary of Glenmark based in the United States.

The trigger for the recall was the detection of N-Nitroso Atomoxetine, a probable human carcinogen, found in concentrations above the permissible limit. The impurity is part of a larger class of nitrosamine contaminants that have plagued global pharmaceutical supply chains in recent years, prompting recalls and regulatory action across multiple geographies.

Recall spans 39 products across therapeutic categories
Focus of recall: Atomoxetine Capsules with N-Nitroso impurity
Voluntary recall initiated by Glenmark, not a forced action

Market Sentiment Turns Negative Amid Broader Industry Concerns

Investor sentiment surrounding Glenmark has deteriorated significantly, as reflected in the stock’s 13 percent decline over the past five trading sessions. The magnitude of the recall and the concerns around CGMP (Current Good Manufacturing Practice) deviations have revived long-standing fears about compliance issues in India’s pharmaceutical exports to regulated markets, especially the United States.

Glenmark’s Pithampur facility has previously undergone multiple regulatory inspections, and while the firm has taken remedial measures in the past, the recurrence of manufacturing concerns has led to renewed fears of potential import alerts or further regulatory actions, even though none have been confirmed as of now.

Investors wary of potential import restrictions or compliance lapses
US remains a key revenue contributor for Indian pharma exporters
CGMP compliance remains under tight scrutiny from global regulators

Recall Raises Questions About Long-Term Revenue and Compliance Track Record

The recall of Atomoxetine and 38 other drugs—though voluntary—raises critical questions about Glenmark’s manufacturing and quality assurance frameworks. Atomoxetine, in particular, is a widely prescribed ADHD medication and represents a notable portion of the company’s generics portfolio in the US market.

Analysts tracking the pharmaceutical sector warn that even voluntary recalls can have long-lasting implications, especially when tied to contamination issues involving carcinogenic compounds. Firms typically have to undergo comprehensive remediation, internal audits, and third-party assessments to restore trust with both regulators and business partners.

Potential revenue disruption from halted drug supply
Long-term costs include remediation, reputational risk
CGMP failures may lead to intensified inspections and compliance costs

Glenmark Yet to Respond Publicly, Analysts Await Clarity on Scope of Impact

While the USFDA’s report offers clarity on the nature and scope of the recall, Glenmark Pharmaceuticals has yet to issue a detailed public statement addressing investor concerns, outlining the corrective steps it intends to take, or providing clarity on the expected timeline for product re-approval and re-launch.

Brokerages are likely to revise their near-term estimates for the company, factoring in potential revenue loss and elevated compliance-related expenditures. A large part of Glenmark’s US revenue is dependent on niche generics like Atomoxetine, and any prolonged disruption could materially impact earnings in the upcoming quarters.

Awaited: Glenmark’s detailed response and roadmap
Brokerages may downgrade near-term revenue outlook
Impact on earnings visibility to be assessed over next two quarters

Atomoxetine Recall Part of Wider USFDA Crackdown on Nitrosamine Impurities

The Glenmark recall is part of a broader trend wherein the USFDA and European regulators have significantly increased scrutiny on nitrosamine impurities in generic formulations. Other major Indian firms like Sun Pharma, Dr. Reddy’s, and Aurobindo have also faced similar recalls in recent years.

The elevated regulatory standards around genotoxic impurities have led many pharma companies to revalidate their testing protocols, update manufacturing processes, and implement stricter raw material screening. Industry experts suggest this trend is likely to continue well into 2026, with the USFDA aggressively targeting lapses in impurity profiling and data integrity.