Proton Pump Inhibitor Recalled

Reports of cracked tablets have prompted Torrent Pharma Inc to recall 2 lots of pantoprazole sodium delayed-release tablets, according to the May 11, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects pantoprazole sodium delayed-release tablets, 20 mg, 90-tablet bottles (NDC 13668-096-90), from lots BA34G021 and BA34G022 (Exp. 9/22). The tablets were manufactured by Torrent Pharmaceuticals Ltd, Indrad, India, for Torrent Pharma Inc, Levittown, PA, and were distributed within the United States.

Torrent Pharma voluntarily initiated the recall April 11, 2022. On May 5, 2022, the FDA designated the recall Class II, communicating use of the medication may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Pantoprazole sodium delayed-release tablets are available with a prescription for the treatment of erosive esophagitis associated with gastroesophageal reflux disease and for the long-term treatment of pathological hypersecretory conditions, such as Zollinger-Ellison syndrome.