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Searched Tag: us food and drug administration usfda

India has the highest number of USFDA-compliant pharmaceutical plants outside of the US

Indian pharma majors recall drugs in US over manufacturing issues

October 12, 2025, 07:55 PM - 2 min read

Dr. Reddy’s and Zydus Lifesciences have recalled drugs manufactured in the USA for “out-of-specification results” and “failed impurity/degradation specifications” respectively

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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

Domestic drug majors recall products in US market

July 27, 2025, 11:01 PM - 3 min read

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

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