Medications & Supplements/Prescription Drugs

Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals: Spironolactone Tablets Recalled for Label Mix-Up and Incorrect Dosage

Agency Publication Date: March 16, 2021

Summary

Bryant Ranch Prepack, Inc. is recalling approximately 47 bottles of Spironolactone (Aldactone) tablets in 25 mg and 50 mg strengths because the bottles may contain the wrong dosage. Bottles labeled as 25 mg tablets may actually contain 50 mg tablets, while bottles labeled as 50 mg may contain 25 mg tablets. This labeling error was discovered after bottles were distributed nationwide in 30, 60, and 90-count sizes. Consumers should check their medication bottles immediately and speak with a pharmacist or healthcare provider to ensure they are taking the correct dose.

Risk

Taking the incorrect dose of Spironolactone can lead to serious health complications, including dangerously high or low potassium levels (electrolyte imbalances) or the ineffective treatment of conditions like high blood pressure and heart failure.

What You Should Do

Check your medication bottle for the product name 'Spironolactone Tablets, USP' and confirm the dosage strength listed on the label (25 mg or 50 mg).
Inspect the label for the following identifying codes: For 25 mg tablets, look for Lot 148969 (Exp 7/31/2022) in 30-count bottles, Lot 148791 (Exp 7/31/2022) in 60-count bottles, or Lot 148991 (Exp 7/31/2022) in 90-count bottles. For 50 mg tablets, look for Lot 148992 (Exp 5/31/2022) in 30-count bottles.
If you have an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on how to confirm your tablet strength and whether you need a replacement.
Return any unused product from the affected lots to your pharmacy for a refund.
Contact Bryant Ranch Prepack, Inc. (BRP Pharmaceuticals) at 1-888-723-3332 if you have questions regarding this recall or your medication.
For additional information or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Spironolactone Tablets, USP, 25 mg (30-count bottle)

Model:

NDC 63629-1064-01

Recall #: D-0303-2021

Lot Numbers:

148969 (Exp 7/31/2022)

Product: Spironolactone Tablets, USP, 25 mg (60-count bottle)

Model:

NDC 63629-1064-02

Recall #: D-0303-2021

Lot Numbers:

148791 (Exp 7/31/2022)

Product: Spironolactone Tablets, USP, 25 mg (90-count bottle)

Model:

NDC 63629-1064-03

Recall #: D-0303-2021

Lot Numbers:

148991 (Exp 7/31/2022)

Product: Spironolactone Tablets, USP, 50 mg (30-count bottle)

Model:

NDC 63629-1067-01

Recall #: D-0304-2021

Lot Numbers:

148992 (Exp 5/31/2022)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87283

Status: Active

Manufacturer: Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Sold By: pharmacies nationwide

Manufactured In: United States

Units Affected: 2 products (35 bottles; 12 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication bottle for the product name 'Spironolactone Tablets, USP' and confirm the dosage strength listed on the label (25 mg or 50 mg).

Inspect the label for the following identifying codes: For 25 mg tablets, look for Lot 148969 (Exp 7/31/2022) in 30-count bottles, Lot 148791 (Exp 7/31/2022) in 60-count bottles, or Lot 148991 (Exp 7/31/2022) in 90-count bottles. For 50 mg tablets, look for Lot 148992 (Exp 5/31/2022) in 30-count bottles.

If you have an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on how to confirm your tablet strength and whether you need a replacement.

Return any unused product from the affected lots to your pharmacy for a refund.

Contact Bryant Ranch Prepack, Inc. (BRP Pharmaceuticals) at 1-888-723-3332 if you have questions regarding this recall or your medication.

For additional information or to report a reaction, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Spironolactone Tablets, USP, 25 mg (30-count bottle)

Model:

NDC 63629-1064-01

Recall #: D-0303-2021

Lot Numbers:

148969 (Exp 7/31/2022)

Product: Spironolactone Tablets, USP, 25 mg (60-count bottle)

Model:

NDC 63629-1064-02

Recall #: D-0303-2021

Lot Numbers:

148791 (Exp 7/31/2022)

Product: Spironolactone Tablets, USP, 25 mg (90-count bottle)

Model:

NDC 63629-1064-03

Recall #: D-0303-2021

Lot Numbers:

148991 (Exp 7/31/2022)

Product: Spironolactone Tablets, USP, 50 mg (30-count bottle)

Model:

NDC 63629-1067-01

Recall #: D-0304-2021

Lot Numbers:

148992 (Exp 5/31/2022)