The recall was voluntarily started by the company's U.S. unit, Zydus Pharmaceuticals USA Inc, on May 8, due to the presence of the high blood pressure medicine atenolol in a bottle containing the allergy drug, promethazine hydrochloride.
Promethazine hydrochloride is commonly used to treat allergic disorders, nausea, vomiting, difficulty sleeping, as well as for pre-operative sedation.
The FDA classified the recall as Class II, which means use of or exposure to the recalled products may cause temporary or medically reversible adverse health consequences.
The bottles being recalled carry an expiry date of September 2015, according to the FDA post.
A Zydus spokesman did not immediately respond to a request for comment.
Recalls of drugs are not uncommon.
However, Zydus's drug recall is the seventh this year by an Indian company, and follows those by other large drugmakers including Wockhardt Ltd, Ranbaxy Laboratories Ltd , Dr. Reddy's Laboratories Ltd, Lupin Ltd , Sun Pharmaceutical Industries Ltd and Glenmark Pharmaceuticals Ltd.
The incidents come at a time when the FDA has increased its scrutiny of Indian drugmakers after the agency banned exports from manufacturing plants of some top drugmakers, including Ranbaxy and Wockhardt, upon finding quality control lapses.