Last Updated on April 22, 2025 by The Health Master
Drug recall
Three major Indian pharmaceutical companies, Glenmark, Sun Pharma, and Zydus, are currently under the microscope in the United States as the US Food and Drug Administration (USFDA) has highlighted their drugs for drug recall due to some manufacturing issues.
According to the latest Enforcement Report issued by the US health regulator, the drug recall highlight the stringent quality control measures in the American pharmaceutical market and the potential impact of manufacturing lapses on patient safety.
Glenmark: Drug Recall
Mumbai-based Glenmark Pharmaceuticals is facing the action, with the USFDA reporting a drug recall of over 25 different drugs within the United States.
The core issue identified by the USFDA is Current Good Manufacturing Practice (CGMP) deviations, indicating potential flaws in the company’s adherence to established quality standards during the production process.
Glenmark Pharmaceuticals Inc., based in New Jersey, is specifically recalling several key medications.
These include affected batches of:
- Propafenone Hydrochloride extended-release capsules
- Solifenacin Succinate Tablets
- Voriconazole Tablets
- Lacosamide Tablets
- Frovatriptan Succinate Tablets
- Rufinamide Tablets
The USFDA classified this as a Class II recall, which signifies a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health issues.
Glenmark initiated this widespread recall on March 13th of this year.
Sun Pharma Drug Recall:
A US-based subsidiary of Sun Pharmaceutical Industries is also facing scrutiny.
The company is recalling approximately 13,700 bottles of Gabapentin capsules.
The New Jersey-based arm of Sun Pharma initiated this drug recall due to “cross contamination,” according to the USFDA.
This drug recall has been classified as a Class III recall, which is initiated in situations where the use of or exposure to a violative drug is not likely to cause adverse health issues.
The drug recall began on March 4, 2025.
Zydus Drug Recall
Zydus Pharmaceuticals (USA) Inc. has started a drug recall of 3,144 bottles of Chlorpromazine Hydrochloride Tablets, USP 10 mg.
The USFDA stated that Zydus is recalling this specific batch of the drug due to CGMP deviations.
Further investigation revealed the “presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.”
Q. What is 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 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.
Q. What is CGMP?
A. CGMP (Current Good Manufacturing Practice) refers to regulations established by the USFDA to ensure that drugs are consistently manufactured according to quality standards.
Q. What are nitrosamine impurities in drugs?
A. Nitrosamines are chemical compounds that can form in drugs during the manufacturing process or storage. Some nitrosamines are also known as probable human carcinogens.
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.
Drug Recall: Strides Pharma recalls Testosterone Gel
Drug Recall: Sun Pharma, Zydus recall drugs due to this reason
Drug recall: Dr. Reddy’s Recalls Levetiracetam in 0.75% Sodium Chloride Injection Due to this reason
Drug recall: Glenmark recalls 15 lakh bottles of this Drug
Karnataka’s new NSQ Drug Recall Policy
Drug recall: Glenmark and FDC recall Drugs due to this issue
USFDA: No animal testing in drug development
USFDA inspection: At Aurobindo Pharma subsidiary with 11 observations
Online Neutral Codes and Certificates for Medical Devices: CDSCO
FDA Maharashtra seizes drugs worth Rs 61.95 lakh
Fake QR Codes on Top medicines uncovered in Gujarat
CDSCO SOPs: New Guidelines for SEZ-Manufactured Drugs in India
Key Notes on Revised Schedule M: API Part-3
18 New Drug Inspectors to Boost Enforcement soon: Tamil Nadu
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
