Sun Pharma, Lupin, Dr Reddy’s Recall Drugs in US Market

Summary:
Three major Indian pharmaceutical companies are remembering drugs in the United States. Sun Pharma is recalling Lisadexamfetamine capsules due to unsuccessful disruption specifications. Lupine is recalling lisinopril and hydrochlorothiazide pills due to the product mix with atazanavir and ritonavir tablets 

In a recent revelation, India’s top drug players – Sun Pharmaceutical Industries, Lupine Limited, and Dr.  Reddy’s have released voluntary recalls of several general drug products in the US market, which are followed by flagged quality and safety concerns by the US Food and Drug Administration (USFDA). These remember, all are classified as Class II events, underlining manufacturing discrepancies and product mix-ups that can offer temporary or medical health risks. 

Sun Pharmaceutical ADHD Medication Fails Dissolution Test  

Sun Pharma U.S. Arm, Sun Pharmaceutical Industries Inc. has initiated a memorial of about 5,448 bottles of lisdexamfetamine, a memorial 60mg capsules, a general posterization is used to manage hyperactivity disorder (ADHD) of attention deficit. The memory, which began from June 16, 2025, was triggered by testing failures in the disintegration profile of the product, which means that drug quality control analysis did not break down. This failure can affect the efficacy and absorption profile of the drug in patients 

 Lupin Blood Pressure Drug Contaminated by Product Mix-Up 

In a separate action by Lupine Pharmaceuticals InC, 58,968 bottles of a Lisinopril hydrochlorothiazide (20mg/12.5mg) have also been called back. Announced by June 20, 2025, recall was inspired by a disturbing product mixture discovered in Nagpur manufacturing facility: Hypertension drug seal bottles include Atazanavir/Ritonavir 300mg/100mg tablets, which is a therapy used for HIV treatment. Such labeling reduces potential risks for patients receiving unexpected antiviral drugs rather than confusion and incorrectly high blood pressure pills. The USFDA has classified it as Class II, which has been given medical risk – even if no serious adverse incidents have been reported. 

Regulatory Context and Industry Implications 

All three memories fall under the class II category of the FDA, when the use of the product can be used “temporary or medically can lead to reversible health results” or where serious consequences are distant. Although there is no injury so far, the U.S. Referred to distribution highlights systemic issues in manufacturing and quality assurance systems on foreign facilities These incidents come amid intensive investigation from the US regulator at Indian manufacturing sites, citing a limit of deficiencies with previous enforcement reports – ranging from poor sterility measures to misunderstandings and impurities specifications. 

Conclusion 

The latest round of memories by Sun Pharma, Lupine, and Dr. Reddy ’confirms the importance of maintaining strong quality systems in global operations, especially when American regulators serve important international markets such as environment. 

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