Class I and II Recalls for Diuretic

Bryant Ranch Prepack Inc., which does business as BRP Pharmaceuticals, is voluntarily recalling 47 bottles of spironolactone because they may contain both 25-mg and 50-mg tablets, according to the March 24, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

The FDA has categorized the recall of the following products Class I, which communicates that use of the affected drug could cause serious adverse health consequences or death:

• spironolactone tablets, 25 mg, in 30-count bottles (NDC 63629-1064-01), from lot 148969 (Exp. 7/31/22);
• spironolactone tablets, 25 mg, in 60-count bottles (NDC 63629-1064-02), from lot 148791 (Exp. 7/31/22); and
• spironolactone tablets, 25 mg, in 90-count bottles (NDC 63629-1064-03), from lot 148991 (Exp. 7/31/22). 

The following recall was designated Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm:

• spironolactone tablets, 50 mg, in 30-count bottles (NDC 63629-1067-01), from lot 148992 (Exp. 5/31/22). 

The recalled tablets were manufactured by Frontida BioPharm Inc., Philadelphia, PA, repackaged by Bryant Ranch Prepack, Burbank, CA, and then distributed throughout the United States. Bryant Ranch Prepack initiated the recalls January 27, 2021. The FDA issued the Class I and Class II designations on March 16, 2021. 

Available with a prescription, spironolactone is a potassium-sparing diuretic used to treat patients with high blood pressure and heart failure.

—Jolynn Tumolo