Medications & Supplements/Prescription Drugs

AvKARE Chlorthalidone Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: June 9, 2025

Summary

AvKARE is recalling 962 cartons of Chlorthalidone Tablets (25 mg), a medication used to treat high blood pressure, because the tablets failed dissolution testing. This defect means the tablets may not break down properly in the body, which could prevent the patient from receiving the full necessary dose of the medication. The recall affects 50-count cartons (containing five 10-count unit dose cards) with lot number 47947 and an expiration date of May 31, 2026. No injuries have been reported to date.

Risk

If the medication fails to dissolve correctly, it may not be absorbed into the bloodstream at the required rate or amount. This can lead to uncontrolled blood pressure and associated cardiovascular risks.

What You Should Do

This recall involves AvKARE Chlorthalidone Tablets, USP, 25 mg, sold in cartons of 50 tablets (five 10-count unit dose cards) with NDC 50268-167-15.
Check your medication packaging for lot number 47947 and an expiration date of 05/31/2026 to see if your supply is included in this recall.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information about this recall.

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: Chlorthalidone Tablets, USP (25 mg, 50 Tablets)by AvKARE

Variants: 25 mg, Tablet, Unit Dose cards (5x10)

Lot Numbers:

47947 (Exp 05/31/2026)

NDC:

50268-167-15

Recall #: D-0461-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96866

Status: Active

Manufacturer: AvKARE

Sold By: Pharmacies; Hospitals; Healthcare Providers

Manufactured In: United States

Units Affected: 962 cartons

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

This recall involves AvKARE Chlorthalidone Tablets, USP, 25 mg, sold in cartons of 50 tablets (five 10-count unit dose cards) with NDC 50268-167-15.

Check your medication packaging for lot number 47947 and an expiration date of 05/31/2026 to see if your supply is included in this recall.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for more information about this recall.