Medications & Supplements/Prescription Drugs

Accord Healthcare, Inc.: Hydrochlorothiazide Tablets Recalled for Potential Mix-Up with Spironolactone

Agency Publication Date: September 11, 2018

Summary

Accord Healthcare, Inc. is recalling approximately 46,632 bottles of Hydrochlorothiazide (12.5 mg) tablets after a customer found that a sealed bottle contained a completely different medication, Spironolactone (25 mg). Hydrochlorothiazide is a diuretic used to treat high blood pressure, while Spironolactone is also a diuretic used for conditions like heart failure and high blood pressure, but they are not interchangeable. This mix-up occurred in 100-count bottles distributed across the United States and Puerto Rico. Consumers who take the wrong medication could experience unintended side effects or lack the necessary treatment for their specific condition.

Risk

Patients taking Spironolactone instead of the prescribed Hydrochlorothiazide may experience hyperkalemia (dangerously high potassium levels), which can lead to serious heart rhythm issues or other complications, especially if they are already taking medications that interact with Spironolactone. Additionally, the patient's intended blood pressure or swelling condition may go untreated while taking the incorrect medication.

What You Should Do

Check your medication bottle immediately to see if it is labeled as Hydrochlorothiazide Tablets USP, 12.5 mg with NDC 16729-182-01.
Verify if your bottle belongs to Lot PW05264 with an expiration date of 11/2019.
If you have an affected bottle, check the tablets inside. The recall was triggered because a bottle labeled as Hydrochlorothiazide was found to contain Spironolactone 25 mg tablets instead.
Contact your healthcare provider or pharmacist immediately if you believe you have been taking the wrong medication or if you have any health concerns.
Return any unused product from the affected lot to your pharmacy for a refund and to obtain the correct medication.
Contact Accord Healthcare, Inc. at 1-866-941-8873 for further instructions regarding this recall.
For additional questions, call 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

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Hydrochlorothiazide Tablets USP, 12.5 mg (100-count bottle)

Model:

NDC 16729-182-01

Recall #: D-1206-2018

Lot Numbers:

PW05264 (Exp. 11/2019)

Date Ranges: Expiration 11/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80850

Status: Resolved

Manufacturer: Accord Healthcare, Inc.

Sold By: pharmacies

Manufactured In: India, United States

Units Affected: 46,632 bottles

Distributed To: Nationwide

Agency Last Updated: September 21, 2018

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

Risk

What You Should Do

Check your medication bottle immediately to see if it is labeled as Hydrochlorothiazide Tablets USP, 12.5 mg with NDC 16729-182-01.

Verify if your bottle belongs to Lot PW05264 with an expiration date of 11/2019.

If you have an affected bottle, check the tablets inside. The recall was triggered because a bottle labeled as Hydrochlorothiazide was found to contain Spironolactone 25 mg tablets instead.

Contact your healthcare provider or pharmacist immediately if you believe you have been taking the wrong medication or if you have any health concerns.

Return any unused product from the affected lot to your pharmacy for a refund and to obtain the correct medication.

Contact Accord Healthcare, Inc. at 1-866-941-8873 for further instructions regarding this recall.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.