Medications & Supplements/Prescription Drugs

Macleods Losartan and Hydrochlorothiazide Tablets Recalled for Impurities

Agency Publication Date: June 27, 2022

Summary

Macleods Pharma USA Inc. is recalling Losartan potassium and Hydrochlorothiazide (100 mg/25 mg) tablets because testing discovered AZIDO impurity levels that are above acceptable safety limits. The recall affects approximately 84 bottles of 1,000 tablets each. No injuries or illnesses have been reported to date in connection with this issue.

Risk

The tablets contain a chemical impurity known as AZIDO at levels higher than the FDA considers safe. Long-term exposure to these impurities above acceptable limits may increase health risks for patients using the medication.

What You Should Do

This recall affects Losartan potassium and Hydrochlorothiazide tablets (100 mg/25 mg) sold in 30, 90, and 1,000-count bottles under the Macleods Pharma USA brand.
Check your medication packaging for Lot number BLM2114A with an expiration date of 07/2023. The product also carries NDC numbers 33342-052-07, 33342-052-10, or 33342-052-44.
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 Macleods Pharma Usa Inc directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information 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 & Hydrochlorothiazide Tablets

Variants: 100 mg/25 mg, 30 count bottle, 90 count bottle, 1000 count bottle

Lot Numbers:

BLM2114A (Exp 07/2023)

NDC:

33342-052-07

33342-052-10

33342-052-44

Quantity affected: 84/1000 count bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90426

Status: Resolved

Manufacturer: Macleods Pharma Usa Inc

Sold By: pharmacies

Manufactured In: United States

Units Affected: 84/1000 count 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 Losartan potassium and Hydrochlorothiazide tablets (100 mg/25 mg) sold in 30, 90, and 1,000-count bottles under the Macleods Pharma USA brand.

Check your medication packaging for Lot number BLM2114A with an expiration date of 07/2023. The product also carries NDC numbers 33342-052-07, 33342-052-10, or 33342-052-44.

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 Macleods Pharma Usa Inc directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.