Aurobindo Pharma recalls 4,608 bottles of pain relieving drug in US

PTI Updated - June 27, 2025 at 03:24 PM.

The drug major is recalling 4,608 bottles of Acetaminophen Tablets (325 mg) in the US due to cGMP deviations, USFDA said in its latest Enforcement Report

Aurobindo Pharma recalls 4,600 bottles of pain relieving drug in US due to manufacturing issues, FDA reports. | Photo Credit: iStockphoto

Aurobindo Pharma is recalling over 4,600 bottles of a pain relieving drug in the US market due to manufacturing issues, according to the US health regulator.

A US-based unit of the Hyderabad-based drug major is recalling 4,608 bottles of Acetaminophen Tablets (325 mg) in the US due to cGMP (Current Good Manufacturing Practices) deviations, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report.

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The affected lot is being recalled "due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets)", it added.

The medication is used to relieve headaches, migraine, toothache, back pain and muscle pain, among other

Princeton-based Aurobindo Pharma USA Inc initiated the Class II recall on May 22 this year.

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.

Shares of Aurobindo Pharma on Friday were trading 0.08 per cent up at ₹1,124.05 apiece on BSE.

Published on June 27, 2025 09:53

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