Class II Recall Active for Pantoprazole

Jubilant Cadista Pharmaceuticals Inc. is recalling 12,960 bottles of pantoprazole sodium delayed-release tablets, 40 mg, because of dark brown discoloration on the edges of tablets. The recall was included in the April 10, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects 90-count bottles (NDC 59746-284-90) from lot PA217060A (Exp. 5/20), which were distributed throughout the United States.

The recall was voluntarily issued by Jubilant Cadista Pharmaceuticals on March 29, 2019. On April 1, 2019, the FDA designated it Class II. The classification suggests use of the product could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists.

Pantoprazole is a prescription proton-pump inhibitor used to treat gastroesophageal reflux disease, a damaged esophagus, or high levels of stomach acid caused by tumors. 

—Jolynn Tumolo