The loratadine and pseudoephedrine sulphate extended release tablets being recalled carry an expiry date of September 2015, and were manufactured by Ranbaxy's Ohm Labs plant in New Jersey, which is the company's only facility making generics for the United States.
All other Ranbaxy plants, based in India, have been banned from exporting generics to the United States after the FDA found manufacturing quality glitches that the agency believed could compromise the quality of medicines.
Rival Indian drugmaker Sun Pharmaceutical Industries Ltd agreed to buy Ranbaxy last month in a $3.2 billion deal, betting it can fix Ranbaxy's problems.
The FDA classified the recall by Ohm Labs as Class II, which means use of or exposure to the recalled products may cause temporary or medically reversible adverse health consequences.
Ranbaxy did not immediately respond to requests for comment.