Why Are Dr Reddy's and Zydus Lifesciences Recalling Medicines in the US?
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Synopsis
In an alarming update, two major Indian pharmaceutical companies, Dr Reddy's and Zydus Lifesciences, are recalling several medications from the US market due to serious quality control issues. This raises questions about safety and regulatory compliance in the pharmaceutical sector.
Key Takeaways
- Dr Reddy's is recalling 571 vials of a muscle relaxant.
- Zydus Lifesciences is recalling over 1,500 boxes of an antiviral.
- Recalls due to manufacturing issues raise safety concerns.
- USFDA maintains strict oversight of pharmaceutical products.
- This highlights the importance of quality control in the industry.
New Delhi, Oct 12 (NationPress) Two prominent Indian pharmaceutical firms, Dr Reddy's Laboratories and Zydus Lifesciences, are withdrawing specific medications from the US market due to manufacturing complications, according to the US health authority.
The recent enforcement update from the US Food and Drug Administration (USFDA) reveals that a US subsidiary of Hyderabad-headquartered Dr Reddy’s is recalling 571 vials of Succinylcholine Chloride Injection, a drug utilized for muscle relaxation.
This recall was triggered on September 26 following the USFDA’s report of an “out-of-specification result” during a six-month stability evaluation.
The affected batch is being recalled nationwide in the United States as a Class II recall, signifying that exposure to this product may lead to temporary or reversible health issues, although serious health risks are deemed unlikely.
In a similar vein, the US division of Zydus Lifesciences, Zydus Pharmaceuticals (USA) Inc, is recalling over 1,500 boxes of Entecavir tablets, an antiviral medication primarily aimed at treating chronic hepatitis B.
This recall, which was initiated on September 24, includes 912 bottles of 0.5 mg tablets and 600 bottles of 1 mg tablets. The USFDA indicated that the recall was due to “failed impurity/degradation specifications.”
India boasts the highest number of USFDA-compliant pharmaceutical plants outside the United States, and these recalls underscore the stringent regulatory scrutiny enforced by US authorities.
This incident is not the first occasion where Indian pharmaceutical manufacturers have had to recall products from the US market.
Previously, companies such as Sun Pharma, Lupin, and Dr Reddy’s have executed similar recalls due to product discrepancies and quality concerns, reaffirming their commitment to patient safety.
In July of this year, Sun Pharmaceutical Industries, based in Mumbai, recalled 5,448 bottles of a generic medication for Attention Deficit Hyperactivity Disorder (ADHD).
The drug in question was Lisdexamfetamine Dimesylate capsules, which failed to meet the necessary dissolution benchmarks during testing.
Point of View
It is crucial to highlight the ongoing challenges faced by pharmaceutical companies in maintaining stringent quality standards. The recalls by Dr Reddy's and Zydus Lifesciences serve as a reminder of the importance of regulatory oversight and the commitment to ensuring patient safety, which must remain a priority for the industry.
NationPress
12/10/2025
Frequently Asked Questions
What medications are being recalled?
Dr Reddy's is recalling 571 vials of Succinylcholine Chloride Injection, while Zydus Lifesciences is recalling over 1,500 boxes of Entecavir tablets.
What triggered the recalls?
The recalls were initiated due to manufacturing quality issues identified by the USFDA, including out-of-specification results and failed impurity specifications.
What does a Class II recall mean?
A Class II recall indicates that exposure to the recalled product may lead to temporary or reversible health problems, though serious health risks are unlikely.
How many recalls have Indian companies made in the past?
This is not the first instance; companies like Sun Pharma and Lupin have previously recalled medications due to quality concerns.
What are the implications for patient safety?
These recalls highlight the necessity for strict regulatory compliance and ongoing quality assurance in the pharmaceutical sector.
