Glenmark recalls product in US over manufacturing issue: USFDA

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.