Dr. Reddy’s Laboratories, a Hyderabad, India-headquartered pharmaceutical company, has issued a voluntary Class III recall for 569,376 bottles of famotidine tablets (over-the-counter, 10-mg, packaged in a 30-count bottle) in the US, due to failed tests for impurities and degradation, specifically for out-of-specification results during routine stability testing at eight- and 24-month stability intervals. The notice was posted in the US Food and Drug Administration weekly enforcement report.

A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. The recall is ongoing and was initiated on October 3, 2017.

Famotidine is used to treat ulcers, gastroesophageal reflux disease and conditions that cause excess stomach acid. It can also treat heartburn caused by acid indigestion.

The drug was made in India and distributed by CVS Pharmacy and Wal-Mart stores.

Source: FDA