Sun Pharma, Lupin, Dr Reddy's recall products in US market due to manufacturing issues
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.
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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", the US health regulator stated.
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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.
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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.
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