‘Failed dissolution specifications’ and ‘presence of foreign tablets’ are some of the reasons listed in the Enforcement Report of US Food and Drug Administration (USFDA) for domestic drug majors Sun Pharma, Lupin, and Dr. Reddy’s Laboratories to recall drugs from the US market.
The US health regulator also elaborated upon the drugs that have been recalled, their use, and the reasons for the recall – all of which started in June, 2025.
The Mumbai-headquartered Sun Pharmaceutical Industries, which has an office in Princeton, US, is recalling 5,448 bottles of a generic medication in the US.
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“Princeton-based Sun Pharmaceutical Industries Inc. is recalling the affected lot of Lisdexamfetamine Dimesylate capsules (60 mg) due to ‘Failed Dissolution Specifications,’” said USFDA in its report.
The medication is used to treat attention deficit hyperactivity disorder (ADHD), and the drug firm initiated the Class II recall in the US on June 16 this year.
As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
Another Mumbai-based drug-maker, Lupin, is recalling 58,968 bottles of a generic combination medication, Lisinopril and Hydrochlorothiazide tablets (USP 20mg/12.5mg), which is used to treat high blood pressure.
Lupin Pharma, which has an office in Naples, initiated the Class II recall on June 20 due to “product mix-up”.
The affected lot was manufactured at the company's Nagpur-based manufacturing facility and is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg, the US health regulator stated.
In another filing, Dr Reddy's Laboratories is recalling 1,476 bottles of Omeprazole delayed-release capsules that are used to treat certain stomach and esophagus problems.
The Princeton-based Dr. Reddy’s Laboratories Inc initiated the Class II recall on June 30, 2025, the USFDA stated, and added that the affected lot was produced at the company’s Bachupally (Telangana)-based manufacturing facility.
The recall is also due to the presence of foreign Divalproex Sodium extended-release 250mg tablets in a bottle of omeprazole capsules, the health regulator added.
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