Glenmark, Dr Reddy''s Recall Products in US: USFDA

New Delhi, Oct 19 (PTI) Drugmakers Glenmark and Dr Reddy's Laboratories are recalling products in the US due to manufacturing issues, 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 Mumbai-headquartered drug maker's Goa manufacturing facility.

The drug firm issued the Class II nationwide recall on September 3, 2025.


USFDA stated that a US-based subsidiary of Dr Reddy's Laboratories is recalling the medication used to provide muscle relaxation during surgery.

Princeton, New Jersey-based Dr. Reddy's Laboratories, Inc is recalling 571 vials of Succinylcholine Chloride Injection due to "out-of-specification results during the 6-month stability testing", USFDA stated.

The company initiated the Class II recall on September 26 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.

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