Sun Pharma, Lupin, Dr Reddy's recall products in US due to mfg issues

Domestic drug majors Sun Pharma, Lupin and Dr Reddy's Laboratories are recalling drugs in the US market due to manufacturing issues and product mix up, according to the US health regulator.

As per the latest Enforcement Report of US Food and Drug Administration (USFDA), the Mumbai-headquartered Sun Pharmaceutical Industries is recalling 5,448 bottles of a generic medication in the US.

Princeton-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Lisdexamfetamine Dimesylate capsules (60 mg) due to "Failed Dissolution Specifications", the US health regulator stated. 

The medication is used to treat attention deficit hyperactivity disorder (ADHD).

The drug firm initiated the Class II recall in the US on June 16 this year, it added.

Another Mumbai-based drug maker Lupin is recalling 58,968 bottles of a generic combination medication used to treat high blood pressure.

Naples-based Lupin Pharmaceuticals Inc is recalling Lisinopril and Hydrochlorothiazide tablets (USP 20mg/12.5mg). The affected lot was manufactured at the company's Nagpur-based manufacturing facility.

As per the USFDA, the company initiated the Class II recall on June 20 due to "Product Mix Up".

This product 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, the US health regulator said that Dr Reddy's Laboratories is recalling 1,476 bottles of Omeprazole Delayed-release capsules.

The medication is used to treat certain stomach and esophagus problems.

Princeton-based Dr. Reddy's Laboratories, Inc initiated the Class II recall on June 30, 2025, USFDA stated.

The affected lot was produced at the company's Bachupally (Telangana)-based manufacturing facility.

The recall is due to the presence of foreign tablets/capsules, USFDA said.

It is due to the presence of foreign Divalproex Sodium extended-release 250mg tablets in a bottle of omeprazole capsules, it added.

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.