Last Updated on May 3, 2025 by The Health Master
Drug recall
Two prominent Indian drug manufacturers, Dr. Reddy’s Laboratories and Lupin, have started drug recall of their drugs in the US market.
These actions, triggered by labeling discrepancies and manufacturing defects, respectively, underscore the rigorous oversight maintained by the US Food and Drug Administration (USFDA) to ensure patient safety and drug efficacy.
Dr. Reddy’s Drug Recall:
Hyderabad-based pharmaceutical company Dr. Reddy’s Laboratories is facing a Class I drug recall of a particular batch of its generic Levetiracetam injection, used in the management of epilepsy.
According to the USFDA’s latest Enforcement Report, the company’s US-based subsidiary is recalling 4,010 bags of Levetiracetam 0.75% in Sodium Chloride Injection (1,000 mg/100 mL).
The issue for the drug recall:
The drug recall starts from a labeling error where the infusion bag was incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL.
Alarmingly, the outer aluminum overwrap packaging correctly identified the product.
This discrepancy may pose a risk to patients, as incorrect dosage information could lead to wrong treatment or adverse effects.
The USFDA has classified this as a Class I drug recall, mentioning the seriousness of the issue.
These types of drug recalls are categorized for the situations where the use of or exposure to a violative drug will cause serious adverse health issues or death.
Dr. Reddy’s started this nationwide drug recall on March 13th of this year.
Lupin Drug Recall:
In a separate development, Mumbai-headquartered Lupin is also under the USFDA’s lens, with its US-based subsidiary, Lupin Pharmaceuticals Inc., initiating a Class II drug recall of an antidepressant drug.
The affected drug, clomiPRAMINE hydrochloride capsules USP, 25 mg, with 2,724 bottles, is being recalled.
The issue for the drug recall:
The reason mentioned by the USFDA for Lupin’s drug recall is “Failed Impurities / Degradation Specifications.”
This indicates that the drug did not meet the required mandatory quality standards, containing unacceptable levels of impurities that may affect the safety and effectiveness of that drug.
A Class II drug recall, as initiated by Lupin on April 18th, is issued when a violative drug may cause temporary or medically reversible adverse health issues or where the probability of serious adverse health issues is remote.
Further, it is less serious than a Class I drug recall.
Q. What does mean by drug recall?
A. A drug recall is an action taken by a pharmaceutical manufacturer to recall a defective drug from the market. This can be due to various reasons, including manufacturing issues, labeling issues, or any safety concerns.
Q. What is a Class I drug recall?
A. Class I Drug Recall: This is the most serious type of drug recall, indicating a reasonable probability that the use of or exposure to a violative drug will cause serious adverse health issues or death.
Q. What is a Class II drug recall?
A. Class II drug recall: A situation in which use of or exposure to a recalled drug may cause temporary or medically reversible adverse health issues.
Q. What is a Class III drug recall?
A. Class III drug recall: A situation in which use of or exposure to a recalled product is not likely to cause adverse health consequences.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
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