Medications & Supplements/Prescription Drugs

Losartan Potassium and Hydrochlorothiazide Recalled for Foreign Plastic

Agency Publication Date: May 15, 2024

Summary

Macleods Pharma USA, Inc. is recalling 1,048 bottles of Losartan Potassium and Hydrochlorothiazide Tablets, USP (50mg / 12.5 mg), used to treat high blood pressure. The recall was initiated because of the presence of a foreign, plastic-like substance found in the product. Consumers who use this medication should contact their healthcare provider or pharmacist to discuss treatment alternatives.

Risk

Ingesting tablets that contain foreign plastic-like material may cause choking or internal irritation of the digestive system.

What You Should Do

This recall affects 1,000-count bottles of Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg / 12.5 mg, labeled with NDC 33342-050-44.
Identify your bottle by checking for Lot Number BLK2304A with an expiration date of 07/31/2025 on the label.
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 additional questions regarding 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: Losartan Potassium and Hydrochlorothiazide Tablets, USP (1000-count bottle)

Variants: 50mg / 12.5 mg

Lot Numbers:

BLK2304A (Exp. 07/31/2025)

NDC:

33342-050-44

Manufactured by Macleods Pharmaceuticals Ltd. in Himachal Pradesh, India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94592

Status: Active

Manufacturer: MACLEODS PHARMA USA, INC

Sold By: Pharmacies

Manufactured In: India

Units Affected: 1,048 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

This recall affects 1,000-count bottles of Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg / 12.5 mg, labeled with NDC 33342-050-44.

Identify your bottle by checking for Lot Number BLK2304A with an expiration date of 07/31/2025 on the label.

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 additional questions regarding this recall.