Generic Nexium Recall Issued After Discolored, Brown Pills Discovered

More than 1,700 bottles of generic Nexium are being recalled, after some of the bottles were found to contain brown or discolored pills.

The FDA announced the generic Nexium recall after the manufacturer discovered discoloration and brown pellets in 1,000-count bottles sold under the Dr. Reddy’s Laboratories label.

No injuries or illnesses have been reported in connection with the recalled Nexium generic pills, and the agency has classified action as Class III recall, meaning it does not believe exposure to the pills is likely to cause any adverse health consequences. However, the recall is being issued out of an abundance of caution.

At least 1,752 bottles are impacted by the recall, which come from one lot of 40 mg Esomeprazole Magnesium delayed release tablets with a lot number of C900642, and an expiration date of 06/2020. The pills were manufactured at Dr. Reddy’s Laboratories Bachupally facility in India and distributed in the U.S. in 1,000-count bottles.

A similar, but much larger recall involving nearly 41,000 bottles of the same product was issued by Dr. Reddy in February 2019, involving pills manufactured at the same plant.

Nexium belongs to a class of medications known as proton pump inhibitors (PPIs), which are designed to reduce the amount of acid in the stomach, treating gastroesophageal reflux disease (GERD), as well as heartburn, ulcers in the stomach and small intestines, and inflammation of the esophagus. Other drugs that belong to the class include some of the biggest selling medications in the U.S., such as Prevacid, Prilosec, Protonix, AcipHex, Dexilant, Vimovo and Zegerid.

While the drugs are used by millions of Americans and widely viewed as safe, concerns have emerged in recent years about the failure to warn about the risk of kidney damage and kidney failure among users.

There are currently more than 13,000 Nexium lawsuits, Protonix lawsuits, Prilosec lawsuits, Prevacid lawsuits  and claims over other PPIs pending in courts nationwide, each raising similar allegations that users developed chronic kidney disease, acute kidney injury or end-stage renal failure, claiming that they may have avoided the diagnosis if warnings had been provided to consumers and the medical community.

Given similar questions of fact and law raised in the complaints, consolidated pretrial proceedings have been established in the federal court system, where all PPI kidney damage lawsuits are centralized before U.S. District Judge Claire C. Cecchi in the District of New Jersey to reduce duplicative discovery into common issues, avoid conflicting pretrial rulings and serve the convenience of the parties, witnesses and the courts.