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Drugmaker Glenmark is recalling a product in the US due to a manufacturing issue, according to the US Food and Drug Administration (USFDA).
As per its latest Enforcement Report, the US health regulator noted that a US-based unit of Glenmark Pharmaceuticals is recalling 26,928 packs of oral contraceptive medication in the US.
Mahwah, New Jersey-based Glenmark Pharmaceuticals Inc., USA is recalling the affected lot of Viorele, Desogestrel and Ethinyl Estradiol (USP, 0.15 mg/ 0.02 mg) and Ethinyl Estradiol tablets due to "failed impurities/degradation specifications." The affected lot was produced at the Mumbai-headquartered drug maker's Goa manufacturing facility.
The drug firm issued the Class II nationwide recall on September 3, 2025.
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.
India has the highest number of USFDA-compliant pharmaceutical plants outside of the US.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
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