Generic drugmaker Dr. Reddy’s Laboratories is recalling more than 500,000 bottles of the acid reducer drug famotidine after the US Food and Drug Administration (FDA) found the batches failed purity and stability tests. This is the second time this year that the India-based pharmaceutical manufacturer has pulled the drug from store shelves.
The over-the-counter (OTC) 10 mg famotidine tablets were sold in bottles of 30 at CVS Pharmacy as store brand acid reducer, and at Walmart as an Equate product. The FDA has classified the recall as Class III, the least serious classification, which indicates that consumption of the affected batches is unlikely to cause harm.
As many as 18 lots of the heartburn drug are affected by the recall, which has been launched nationwide.
Dr. Reddy’s last recall of famotidine was issued in July, when over 84,000 bottles of the acid reducer were pulled from the market. The generics manufacturer has seen a number of regulatory issues over the past year, with three of its facilities being cited following FDA inspections since January.
Dr. Reddy’s is one of India’s largest pharmaceutical companies, alongside Sun Pharmaceutical and Lupin Ltd. In 2016, the company reported115 billion rupees in revenues from its global generics business. This equates to about $176 million, and represents 82 percent of Dr. Reddy’s overall business.