Dr. Reddy's Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., due to Mislabeling of Infusion Bag

Rhea-AI Summary

Dr. Reddy's Laboratories (NYSE: RDY) has initiated a nationwide recall of one batch (Lot No: A1540076) of Levetiracetam in 0.75% Sodium Chloride Injection in the United States due to critical mislabeling. The infusion bags are incorrectly labeled as containing 500 mg/100 mL when they actually contain 1,000 mg/100 mL.

The affected batch was distributed nationwide between November 4-6, 2024. This mislabeling could result in patients receiving double the intended dose, potentially leading to serious side effects including hypersensitivity reactions, liver injury, hematological toxicity, and respiratory depression. Patients receiving high doses for status epilepticus treatment are at highest risk.

While no adverse events have been reported, Dr. Reddy's is instructing wholesalers, distributors, hospitals, and pharmacies to immediately stop use, quarantine, and return affected products. The medication is indicated for adjunct therapy in adults with partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures when oral administration isn't feasible.

Positive

• Swift voluntary recall action demonstrates strong quality control response
• No adverse events reported to date
• to single batch/lot number, minimizing financial impact

Negative

• Nationwide product recall due to critical mislabeling error
• Risk of double-dose administration could lead to serious adverse effects
• Potential liability and regulatory scrutiny from FDA
• Distribution disruption of an important epilepsy medication
• Costs associated with product recall and replacement

Insights

Pharmaceutical Industry Expert

Dr. Reddy's nationwide recall of Levetiracetam injection represents a significant quality control failure with potential clinical consequences. The mislabeling error - where bags containing 1,000 mg/100 mL were incorrectly labeled as 500 mg/100 mL - creates a dangerous double-dosing risk for patients.

This type of medication error is particularly concerning for an antiepileptic drug. Patients could experience severe adverse effects including hypersensitivity reactions, liver injury, hematological toxicity, and neurological complications like somnolence, respiratory depression, and potentially coma. Those being treated for status epilepticus face the highest risk.

While no adverse events have been reported yet, this recall highlights critical gaps in Dr. Reddy's quality assurance processes. The error occurred despite correct labeling on the outer aluminum packaging, indicating a breakdown in final verification procedures.

The distribution window (November 4-6, 2024) may mitigate some impact, but the company still faces potential regulatory consequences and litigation risk if patient harm occurs. For investors, this raises concerns about Dr. Reddy's manufacturing quality controls and compliance procedures which could invite greater FDA scrutiny across their product portfolio.

Healthcare Regulatory Analyst

This recall represents a Class II medication error with significant regulatory implications for Dr. Reddy's. The mislabeling creates a critical patient safety issue where the delivered dose (1,000 mg) is double what healthcare providers would expect based on the primary container label (500 mg).

From a regulatory perspective, this error reveals failures in Dr. Reddy's Corrective and Preventive Action (CAPA) systems. The FDA will likely initiate a thorough investigation into how this discrepancy between the infusion bag and overwrap labeling occurred and passed quality control checks. This could potentially result in a Form 483 observation or warning letter depending on the company's history of compliance.

While the recall is voluntary and proactive, the severity of potential patient harm elevates its regulatory significance. The FDA's involvement signals potential for enhanced inspections across manufacturing facilities and scrutiny of the company's Good Manufacturing Practice (GMP) compliance.

For Dr. Reddy's, this comes with both immediate costs (product retrieval, replacement, logistics) and potential longer-term regulatory consequences including possible penalties, mandatory corrective actions, and increased inspection frequency. The company may face additional reporting requirements and enhanced oversight until they can demonstrate robust remediation of the underlying quality system deficiencies.

HYDERABAD, India--(BUSINESS WIRE)-- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”), is recalling one Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags to the consumer level, in the United States.

Product Overwrap Description - Levetiracetam in 0.75% Sodium Chloride Injection (1,000 mg/100 mL) (Photo: Business Wire)

The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

Risk Statement: Patients who are administered the mislabeled product will likely experience adverse events. Because the infusion bag is labelled as 500 mg/100 mL but actually contains 1,000 mg/100 mL dose, the patient could receive double the dose of intravenous levetiracetam than intended which could lead to immediate and serious side effects including hypersensitivity reactions, liver injury, hematological toxicity, somnolence, fatigue, dizziness, coordination difficulties, agitation, aggression, depressed level of consciousness, respiratory depression, and coma. Patients receiving high doses of levetiracetam by rapid intravenous infusion for the treatment of status epilepticus would be most at risk for severe adverse events. Dr. Reddy’s has not received any reports of adverse events related to this recall.

Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) and Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg/100 mL (5mg/mL) are both indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible:
- Partial onset seizures
- Myoclonic seizures in patients with juvenile myoclonic epilepsy
- Primary generalized tonic-clonic seizures

Each product is packaged in single-dose infusion bags with an aluminum overwrap, 10 single-dose bags packed in a carton. Identification information such as lot number, expiration date and NDC is presented in the table below. The batch was distributed nationwide between November 4, 2024, and November 6, 2024, to wholesalers.

DESCRIPTION OF MISLABELLED BAGS BEING RECALLED:

NDC Number	Product Overwrap Description	Product Infusion Bag Primary Description	Lot Number	Expiration Date
43598-635-52	Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL	Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag.	A1540076	08/2026
43598-636-52	Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL	Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL single-dose bag	A1540076	08/2026

DESCRIPTION OF CARTON BEING RECALLED:

NDC Number	Carton Description	Lot Number	Expiration Date
43598-636-10	Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL 10 Single-Dose Bags	A1540076	08/2026

Dr. Reddy’s Laboratories, Inc is notifying its distributors and customers to arrange for return of any recalled product. Wholesalers, distributors, hospitals, and pharmacies with an existing inventory of the lot being recalled should stop use and distribution and quarantine the product immediately for return/replacement of all recalled products. Wholesalers, distributors, and pharmacies that have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product from them. For instructions on returning product or additional assistance, call Inmar at 1-877-645-1584 between the hours of 9 a.m. to 5 p.m. ET, Monday through Friday.

Consumers with questions regarding this recall can contact Dr. Reddy’s Medical Information Call Center at 1-888-375-3784 (1-888-DRL-DRUG) between the hours of 8 a.m. to 8 p.m. ET, Monday through Friday. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality concerns experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online at www.fda.gov/medwatch/report.htm.
• Regular Mail or Fax: Download form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being executed with the knowledge of the U.S. Food and Drug Administration.

RDY-0325-782

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2024. The company assumes no obligation to update any information contained herein.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250313917328/en/

INVESTOR RELATIONS

RICHA PERIWAL

RICHAPERIWAL@DRREDDYS.COM

MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Dr. Reddy’s Laboratories Ltd.

FAQ

What is the specific batch of RDY's Levetiracetam being recalled in 2024?

Batch/Lot No: A1540076 of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL, distributed between November 4-6, 2024.

Why is Dr. Reddy's recalling this batch of Levetiracetam injection?

Due to mislabeling where infusion bags show 500 mg/100 mL instead of the actual 1,000 mg/100 mL content, risking double-dose administration to patients.

What are the potential risks of using the mislabeled RDY Levetiracetam injection?

Patients could receive double the intended dose, risking serious side effects including liver injury, hypersensitivity reactions, respiratory depression, and coma.

How should healthcare providers handle the recalled RDY Levetiracetam products?

They should immediately stop use, quarantine the product, and arrange for return through Inmar at 1-877-645-1584.

Have there been any reported adverse events from the mislabeled RDY Levetiracetam?

No adverse events have been reported related to this recall as of the announcement date.