Multiple drugmakers have had to yank their products in the U.S. this year over manufacturing and quality concerns.
A trio of drugmakers have issued separate recalls in the U.S. thanks to string of production flubs, including failed impurity and dissolution specifications and incorrect labelling of infusion bags.The companies behind the product pulls are Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, all three of which hail from India. The drugmakers are recalling seizure treatments, painkillers and a chemotherapy drug, respectively, according to the FDA’s online enforcement report, which the regulator uses to catalogue recalls. In the case of Dr. Reddy’s, the company unveiled a voluntary recall on March 13 for one lot of 1,000 mg/100 ml single-dose levetiracetam infusion bags that had been shipped out across the U.S. in early November. The infusion bags from the suspect batch were incorrectly labeled as 500 mg/100 ml levetiracetam in 0.82% sodium chloride injection, while the aluminum overwrap packaging correctly identifies the product as levetiracetam in 0.75% sodium chloride injection 1,000 mg/100 ml, Dr. Reddy’s explained in its recall notice.Levetiracetam is typically used to treat certain types of seizures when patients are unable to take an oral medication. Although Dr. Reddy’s says there have so far been no reported safety events related to the product pull, patients receiving higher-than-expected doses of the drug by rapid intravenous infusion are at risk of “immediate and serious side effects,” including liver injury, respiratory depression and coma, the company explained. Sun Pharma, for its part, is recalling nearly 10,000 100 mg bottles of morphine sulfate extended-release tablets after the products failed to meet FDA dissolution specifications. The painkillers are part of lot AD16615, which was set to expire in July. The morphine sulfate tablets at issue were distributed nationwide, according to the FDA’s enforcement report.Sun initiated the Class II recall on Feb. 6. The tablets were manufactured by the Indian drugmaker’s subsidiary Ohm Laboratories in New Brunswick, New Jersey.Lastly, Zydus Pharmaceuticals initiated two separate Class II recalls on Feb. 13 covering a whopping 38,871 vials of the chemotherapy injection nelarabine, which were manufactured at the company’s Ahmedabad, India, production facility.The drugmaker issued the recall due to failed impurity and degradation specifications, the FDA’s enforcement report notes.The far-reaching product pull accounts for more than 20 lots of the chemotherapy med, which were set to expire as early as last month or as late as July 2026, depending on the specific batch. Multiple drugmakers have had to yank their products in the U.S. this year, with one recent recall yielding significant interest for its scope and treatment type.Earlier this month, Glenmark Pharma revealed it was recalling some 1.48 million bottles of the generic attention-deficit/hyperactivity disorder (ADHD) drug atomoxetine after detecting unacceptable levels of a possible carcinogen in the product.Atomoxetine—previously sold by Eli Lilly under the brand name Strattera—is a selective norepinephrine reuptake inhibitor (sNRI) independent of the stimulant-based offerings that make up the bulk of ADHD treatment.
