Sun Pharma, Lupin, and Dr. Reddy's Issue Product Recalls In The U.S. Market

Top pharma players Dr Reddy, Lupin, and Sun Pharma are reportedly recalling drugs from the US market as a result of manufacturing faults  an product mix up, as per the US Food and Drug Administration (FDA).

According to media reports, US FDA's latest enforcement report mentioned that Sun Pharmaceuticals Industries is recalling 5,445 generic medication units in the U.S.

Further, the U.S health regulator said the drug major's recall move comes as a direct result of "Failed Dissolution Specifications",

This medication is utilized to treat attention deficit hyperactivity disorder. The drug firm initiated the Class II recall in the US on June 16 this year, it added.

Meanwhile, the Mumbai-headquartered pharma major 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 . 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 -based manufacturing facility.

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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 said.

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.