The company is recalling the lot "due to below specification results for assay", it added.
The drug is manufactured by Novel Laboratories Inc for Baltimore-based Lupin Pharmaceuticals, Inc.
The ongoing, voluntary recall is a class II recall, the report said.
As per USFDA, a class II recall is initiated in a situation "in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Lupin shares were trading 1.15 per cent down at Rs 831.80 apiece on the BSE.