Medications & Supplements/Prescription Drugs

Spironolactone Tablets Recalled for Aluminum Contamination

Agency Publication Date: August 7, 2025

Summary

Sun Pharmaceutical Industries Inc is recalling 11,328 bottles of Spironolactone (25 mg), a prescription medication used to treat high blood pressure and fluid retention. The recall was initiated because a foreign substance, identified as aluminum, was found in the product. The affected medication was distributed nationwide in 100-count bottles.

Risk

Ingesting foreign substances like aluminum fragments in oral medication can cause irritation or physical injury to the digestive system. No injuries have been reported in the current data.

What You Should Do

The recalled medication is Spironolactone Tablets, USP, 25 mg, sold in 100-count bottles with NDC 53489-143-01.
Identify affected bottles by checking for lot number P3314 and an expiration date of 11/30/2026 printed on the label.
If you have health concerns or are worried about your treatment, contact your healthcare provider or pharmacist before making changes to your prescribed medication.
Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Spironolactone Tablets, USP, 25 mg (100-count bottle)

Variants: 25 mg, 100-count bottle

Lot Numbers:

P3314 (Exp 11/30/2026)

NDC:

53489-143-01

Manufactured by Frontida BioPharm, Inc. and distributed by Sun Pharmaceutical Industries, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97391

Status: Active

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 11,328 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

The recalled medication is Spironolactone Tablets, USP, 25 mg, sold in 100-count bottles with NDC 53489-143-01.

Identify affected bottles by checking for lot number P3314 and an expiration date of 11/30/2026 printed on the label.

If you have health concerns or are worried about your treatment, contact your healthcare provider or pharmacist before making changes to your prescribed medication.

Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Inc for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.