Sun Pharma, Lupin, Dr. Reddy's
Sun Pharma, Lupin, Dr. Reddy's: Pharma stocks may see some pressure tomorrow; here is why
As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), the Mumbai-headquartered Sun Pharmaceutical Industries is recalling 5,448 bottles of a generic medication in the US.
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.
Shares of India's leading pharmaceutical companies Sun Pharma, Lupin, and Dr. Reddy's will be in the spotlight on Monday, July 28, 2025, as these companies are recalling drugs in the US market due to manufacturing issues and product mix-ups, according to the US health regulator, USFDA.
As per the latest Enforcement Report of the 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 20 mg/12.5 mg). 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 a "product mix-up." This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg had a foreign tablet identified as an atazanavir and ritonavir tablet 300 mg/100 mg, 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 oesophagus problems. Princeton-based Dr. Reddy's Laboratories, Inc., initiated the Class II recall on June 30, 2025, the 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, the USFDA said.
It is due to the presence of foreign Divalproex Sodium extended-release 250 mg 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.
