Spironolactone Tablets (Bryant Ranch) – Label Mix-Up (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01
Brand
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Lot Codes / Batch Numbers
Lot #: 148992, Exp 5/31/2022
Products Sold
Lot #: 148992, Exp 5/31/2022
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals is recalling Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida due to Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026