Spironolactone Tablets Recalled Due to Potential Labeling Mix-Up
Bryant Ranch Prepack is recalling 12 bottles of Spironolactone 50 mg tablets because they may contain 25 mg tablets due to a labeling error.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where a lower dose may be dispensed instead of the prescribed dose, which fits the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals is recalling 12 bottles of Spironolactone Tablets, USP, 50 mg. The product is packaged in 30-count bottles and is available by prescription only. The specific lot number is 148992, with an expiration date of 5/31/2022.
The recall was initiated due to a labeling mix-up. Prepackaged bottles labeled as containing spironolactone 50 mg may actually contain spironolactone 25 mg tablets. The product was manufactured by Frontida BioPharm, Inc. and repackaged by Bryant Ranch Prepack, Inc.
The affected product was distributed nationwide in the USA. Patients and healthcare providers should verify the contents of their medication and contact their pharmacist or healthcare provider for guidance on how to proceed.
The recalled product
- 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
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 148992
- Exp 5/31/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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