March 26, 2021
Breckenridge Pharmaceutical Inc. is recalling 3146 bottles of omeprazole delayed-release capsules because samples tested out-of-specification for unknown impurities during stability testing, according to the March 24, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects omeprazole delayed-release capsules, 20 mg, 1000-count bottles (NDC 51991-643-10), from lot 191659 (Exp. 5/21). The capsules were manufactured by Tow Pharmaceutical Europe, Barcelona, Spain, and distributed by Breckenridge Pharmaceutical throughout the United States.
Breckenridge Pharmaceutical voluntarily initiated the recall March 11, 2021. On March 18, 2021, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.
Omeprazole 20-mg capsules are available with a prescription for the treatment of gastroesophageal reflux disease, ulcers, and other conditions in which the stomach produces too much acid.