Dr. Reddy’s Laboratories recalls Levetiracetam Injection in U.S. over mislabeling concerns

Dr. Reddy’s Laboratories Limited has initiated a nationwide recall of a batch of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL in the United States due to a serious labeling error that could pose significant health risks to patients. The recall affects batch number A1540076, which was distributed to wholesalers across the country between November 4 and November 6, 2024.

The issue arose because the infusion bag itself was mislabeled, indicating that it contained Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg/100 mL, despite the outer aluminum overwrap being correctly labeled. This discrepancy could lead to patients unknowingly receiving twice the intended dose, raising significant concerns for those receiving intravenous levetiracetam for seizure control.

Why Is Dr. Reddy’s Laboratories Recalling Levetiracetam Injection?

The recall stems from the risk of overdosing patients due to the incorrect labeling on the infusion bag. Patients who require levetiracetam intravenously are often in urgent medical situations, such as status epilepticus, where accurate dosing is critical. Because the bag appears to indicate a 500 mg/100 mL concentration while actually containing 1,000 mg/100 mL, healthcare providers could administer double the intended dose, leading to serious and potentially life-threatening adverse effects.

Dr. Reddy’s Laboratories has assured healthcare providers that there have been no reports of adverse events related to this recall. However, as a precautionary measure, the company is working with distributors and healthcare facilities to ensure immediate removal of the affected product from circulation.

What Are the Potential Health Risks of the Mislabeling Issue?

A patient receiving double the intended dose of levetiracetam may experience severe side effects, including respiratory depression, coma, extreme fatigue, coordination difficulties, hypersensitivity reactions, and potential liver damage. The risk is particularly concerning for patients with pre-existing conditions or those requiring high doses for emergency seizure treatment.

Neurological symptoms such as dizziness, somnolence, agitation, and confusion are among the primary concerns. Since levetiracetam is an antiepileptic drug, incorrect dosing could also increase the risk of breakthrough seizures or worsening of neurological conditions.

What Is Levetiracetam Used For, and Who Is Affected by the Recall?

Levetiracetam is a widely prescribed anticonvulsant used as an adjunct therapy for patients aged 16 and older who experience partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures. The recalled batch was distributed to wholesalers, hospitals, and pharmacies across the U.S., making it crucial for healthcare providers to verify their stock to prevent accidental administration.

The product is packaged in single-dose infusion bags, wrapped in an aluminum overwrap, and distributed in cartons containing 10 infusion bags each. Healthcare providers who have received the affected batch are being urged to discontinue use immediately and arrange for product returns through designated recall channels.

What Steps Should Healthcare Providers Take Following the Recall?

Dr. Reddy’s Laboratories is working closely with distributors and regulatory authorities to ensure the immediate removal of the affected product. Healthcare providers and pharmacists are being advised to quarantine the recalled batch, notify their supply chain partners, and arrange for product returns.

Hospitals and clinics should also review patient records to determine if any patients may have been administered the mislabeled product. While no adverse events have been reported, patients who recently received intravenous levetiracetam treatment should be monitored for signs of overdose.

For additional support, medical professionals can contact Dr. Reddy’s Medical Information Call Center at 1-888-375-3784, available Monday through Friday from 8 a.m. to 8 p.m. ET. Patients experiencing any unusual symptoms after receiving the medication are encouraged to contact their healthcare provider immediately.

How Is the U.S. FDA Responding to the Recall?

The U.S. Food and Drug Administration (FDA) has been notified of the recall and is working with Dr. Reddy’s Laboratories to ensure compliance with safety regulations. The agency is advising healthcare providers and consumers to report any adverse reactions or quality issues through the FDA’s MedWatch Adverse Event Reporting Program.

What Could This Recall Mean for Dr. Reddy’s Laboratories’ Stock Performance?

As a publicly traded company listed on the National Stock Exchange of India (NSE: DRREDDY), BSE Limited (BSE: 500124), and the New York Stock Exchange (NYSE: RDY), Dr. Reddy’s Laboratories’ recall announcement could influence investor sentiment. Pharmaceutical recalls, particularly those related to potential safety risks, often lead to short-term fluctuations in stock price as investors assess the financial and reputational impact.

Market analysts will be closely monitoring how this recall affects Dr. Reddy’s share performance, particularly in the U.S. market, where regulatory compliance and drug safety are closely scrutinized. While no direct financial losses have been reported, investors will be watching for any additional regulatory actions or legal implications stemming from the recall.

What Are the Next Steps for Dr. Reddy’s Laboratories?

Dr. Reddy’s Laboratories has committed to strengthening its quality control processes to prevent similar issues in the future. The company, which has a strong presence in the global generics market, has emphasized its commitment to patient safety and regulatory compliance.

Moving forward, the company is expected to work closely with the FDA to complete the recall process while ensuring that all mislabeled products are safely removed from circulation. Given the significance of levetiracetam as an anticonvulsant medication, regulatory agencies will likely continue to monitor compliance efforts and safety measures implemented by the company.

What This Recall Means for Patients and Healthcare Providers

The nationwide recall of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL by Dr. Reddy’s Laboratories highlights the critical importance of accurate pharmaceutical labeling and patient safety. While no adverse events have been reported, the risk posed by double dosing due to mislabeling makes this recall a necessary precautionary measure.

Healthcare providers should take immediate action to remove the affected product from their inventory and ensure that patients receive the correct dosage for their condition. Patients who have recently received intravenous levetiracetam treatment should consult their healthcare provider if they experience any unexpected symptoms.

As regulatory bodies oversee the recall process, Dr. Reddy’s Laboratories will likely implement stricter quality control protocols to reinforce trust in its pharmaceutical products. This incident underscores the need for rigorous oversight in drug manufacturing and distribution, ensuring that patient safety remains a top priority.