Why Are Sun Pharma, Lupin, and Dr Reddy's Recalling Medicines in the US?
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Synopsis
In a concerning move for Indian pharmaceutical firms, Sun Pharma, Lupin, and Dr Reddy's have initiated recalls of numerous medications in the US market due to serious quality control issues. This article explores the implications of these recalls and what they mean for consumers.
Key Takeaways
- Sun Pharma recalls 5,448 bottles of ADHD medication.
- Lupin recalls 58,968 bottles of high blood pressure drug.
- Dr Reddy's recalls 1,476 bottles of Omeprazole capsules.
- All recalls stem from serious quality control issues.
- USFDA has classified these recalls as Class II.
Mumbai, July 27 (NationPress) Indian pharmaceutical companies Sun Pharma, Lupin, and Dr Reddy's Laboratories are in the process of recalling certain medications from the US market due to manufacturing defects and product mix-ups, as indicated by the latest enforcement report from the US Food and Drug Administration (USFDA).
Sun Pharmaceutical Industries, based in Mumbai, is recalling a total of 5,448 bottles of a generic medication designed to treat Attention Deficit Hyperactivity Disorder (ADHD).
The drug involved in this recall is Lisdexamfetamine Dimesylate capsules, which did not meet the necessary dissolution criteria during laboratory evaluations.
This recall was initiated by Sun's US subsidiary, Sun Pharmaceutical Industries Inc. located in Princeton, on June 16. The USFDA has categorized this recall as a Class II recall.
Lupin, another prominent pharmaceutical manufacturer from Mumbai, is recalling 58,968 bottles of a generic medication intended for the treatment of high blood pressure.
The medication in question is a combination of Lisinopril and Hydrochlorothiazide tablets, which were produced at Lupin’s facility in Nagpur, and the recall was executed by its US division, Lupin Pharmaceuticals Inc., situated in Naples.
This recall commenced on June 20, following a report that a sealed bottle of the blood pressure medication contained an entirely different drug—Atazanavir and Ritonavir tablets, which are utilized in HIV treatment.
The USFDA identified this as a case of "Product Mix-Up" and also classified it as a Class II recall.
In a comparable incident, Dr Reddy's Laboratories is recalling 1,476 bottles of Omeprazole delayed-release capsules, commonly used for treating stomach and oesophagus issues.
The recall, according to the USFDA, was initiated by Dr Reddy’s US division, based in Princeton, on June 30. The affected batch was manufactured at the company’s Bachupally facility in India.
The reason for this recall was the discovery of foreign tablets—specifically, Divalproex Sodium extended-release tablets—inside bottles that should have only contained Omeprazole capsules.
As per the USFDA, a Class II recall is issued when the use of a defective product could lead to temporary or medically reversible health issues, although the risk of severe health complications remains low.
Point of View
It is vital to address these recalls with a focus on public safety and health standards. The actions taken by Sun Pharma, Lupin, and Dr Reddy's highlight the importance of rigorous quality control in pharmaceutical manufacturing. We advocate for transparency and consumer protection in the face of such concerns, ensuring that public health remains a priority.
NationPress
27/07/2025
Frequently Asked Questions
What prompted the recalls by Sun Pharma, Lupin, and Dr Reddy's?
The recalls were prompted by manufacturing issues and product mix-ups that failed to meet safety and quality standards as identified by the USFDA.
What types of medications are being recalled?
The recalls involve medications used for ADHD, high blood pressure, and stomach-related conditions.
What does a Class II recall mean?
A Class II recall indicates that the use of a defective product may cause temporary health issues but poses a low risk of severe complications.
