Medications & Supplements/Prescription Drugs

Macleods Losartan Blood Pressure Tablets Recalled for Excessive Impurities

Agency Publication Date: May 3, 2022

Summary

Macleods Pharma USA Inc is recalling approximately 18,912 units of Losartan Potassium and Losartan Potassium & Hydrochlorothiazide (HCTZ) tablets due to azido impurity levels that exceed acceptable safety limits. These prescription medications are used to treat high blood pressure. While millions of individual tablets are affected across various strengths and bottle sizes, there have been no reports of illness or injury to date. The products were distributed to pharmacies nationwide.

Risk

The medications contain levels of an azido impurity that are higher than the acceptable limits set by the FDA. Excessive exposure to these impurities may pose a potential long-term health risk.

What You Should Do

This recall affects Losartan Potassium and Losartan Potassium & Hydrochlorothiazide (HCTZ) tablets sold under the Macleods Pharma USA Inc brand, including strengths of 25 mg, 50 mg, 100 mg, 50/12.5 mg, 100/25 mg, and 100/12.5 mg. Check your medication bottle for NDC numbers starting with 33342 and the manufacturer name 'Macleods Pharma USA, Inc.' See the Affected Products section below for the full list of affected codes.
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 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 additional assistance.

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 Tablets, USP, 25 mg

Variants: 90-count bottles, 1000-count bottles

Lot Numbers:

BLH2002A (Exp 11/2022)

BLH2003B (Exp 11/2022)

BLH2004A (Exp 11/2022)

NDC:

33342-044-10

33342-044-44

MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536. Quantity: 12,408/90 count bottles; 1670/1000 count bottles = 2,786,720 tablets.

Product: Losartan Potassium Tablets, USP, 50 mg

Variants: 30-count bottles, 90-count bottles, 1000-count bottles

Lot Numbers:

BLI2002A (Exp 11/2022)

BLI2004A (Exp 11/2022)

BLI2104B (Exp 05/2023)

NDC:

33342-045-07

33342-045-10

33342-045-44

MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536. Quantity: 3,216/30 count bottles; 47,904/90 count bottles; 4,269/1000 count bottles = 8,676,840 tablets.

Product: Losartan Potassium Tablets, USP, 100 mg

Variants: 30-count bottles, 90-count bottles, 1000-count bottles

Lot Numbers:

BLI2107B (Exp 06/2023)

BLI2101A (Exp 12/2022)

BLI2103A (Exp 12/2022)

BLI2105A (Exp 05/2023)

NDC:

33342-046-07

33342-046-10

33342-046-44

MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536. Quantity: 3,288/30 count bottles; 23,904/90 count bottles; 3,364/1000 count bottles = 5,614,000 tablets.

Product: Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg

Variants: 30-count bottles, 90-count bottles, 1000-count bottles

Lot Numbers:

BLK2107B (Exp 05/2023)

BLK2101A (Exp 01/2025)

BLK2102A (Exp 02/2025)

BLK2103B (Exp 02/2023)

BLK2103C (Exp 02/2023)

BLK2104A (Exp 05/2023)

NDC:

33342-050-07

33342-050-10

33342-050-44

MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536.

Product: Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg

Variants: 30-count bottles, 90-count bottles, 1000-count bottles

Lot Numbers:

BLM2106B (Exp 05/2023)

BLM2101A (Exp 01/2025)

BLM2102A (Exp 02/2023)

BLM2106A (Exp 05/2023)

BLM2103B (Exp 02/2023)

BLM2104A (Exp 05/2023)

BLM2110A (Exp 06/2023)

NDC:

33342-052-07

33342-052-10

33342-052-44

MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536.

Product: Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg

Variants: 30-count bottles, 90-count bottles, 1000-count bottles

Lot Numbers:

BLL2107B (Exp 05/2023)

BLL2101A (Exp 01/2025)

BLL2102A (Exp 02/2025)

BLL2103B (Exp 02/2023)

BLL2104A (Exp 05/2023)

NDC:

33342-051-07

33342-051-10

33342-051-44

MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90037

Status: Resolved

Manufacturer: Macleods Pharma Usa Inc

Sold By: Pharmacies nationwide

Manufactured In: United States

Units Affected: 3 products (12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets; 3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets; 3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets)

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 Losartan Potassium & Hydrochlorothiazide (HCTZ) tablets sold under the Macleods Pharma USA Inc brand, including strengths of 25 mg, 50 mg, 100 mg, 50/12.5 mg, 100/25 mg, and 100/12.5 mg. Check your medication bottle for NDC numbers starting with 33342 and the manufacturer name 'Macleods Pharma USA, Inc.' See the Affected Products section below for the full list of affected codes.

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 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 additional assistance.

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 Tablets, USP, 25 mg

Variants: 90-count bottles, 1000-count bottles

Lot Numbers:

BLH2002A (Exp 11/2022)

BLH2003B (Exp 11/2022)

BLH2004A (Exp 11/2022)

NDC:

33342-044-10

33342-044-44

MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536. Quantity: 12,408/90 count bottles; 1670/1000 count bottles = 2,786,720 tablets.

Product: Losartan Potassium Tablets, USP, 50 mg

Variants: 30-count bottles, 90-count bottles, 1000-count bottles

Lot Numbers:

BLI2002A (Exp 11/2022)

BLI2004A (Exp 11/2022)

BLI2104B (Exp 05/2023)

NDC:

33342-045-07

33342-045-10

33342-045-44

MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536. Quantity: 3,216/30 count bottles; 47,904/90 count bottles; 4,269/1000 count bottles = 8,676,840 tablets.

Product: Losartan Potassium Tablets, USP, 100 mg

Variants: 30-count bottles, 90-count bottles, 1000-count bottles

Lot Numbers:

BLI2107B (Exp 06/2023)

BLI2101A (Exp 12/2022)

BLI2103A (Exp 12/2022)

BLI2105A (Exp 05/2023)

NDC:

33342-046-07

33342-046-10

33342-046-44

MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536. Quantity: 3,288/30 count bottles; 23,904/90 count bottles; 3,364/1000 count bottles = 5,614,000 tablets.

Product: Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg

Variants: 30-count bottles, 90-count bottles, 1000-count bottles

Lot Numbers:

BLK2107B (Exp 05/2023)

BLK2101A (Exp 01/2025)

BLK2102A (Exp 02/2025)

BLK2103B (Exp 02/2023)

BLK2103C (Exp 02/2023)

BLK2104A (Exp 05/2023)

NDC:

33342-050-07

33342-050-10

33342-050-44

MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536.

Product: Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg

Variants: 30-count bottles, 90-count bottles, 1000-count bottles

Lot Numbers:

BLM2106B (Exp 05/2023)

BLM2101A (Exp 01/2025)

BLM2102A (Exp 02/2023)

BLM2106A (Exp 05/2023)

BLM2103B (Exp 02/2023)

BLM2104A (Exp 05/2023)

BLM2110A (Exp 06/2023)

NDC:

33342-052-07

33342-052-10

33342-052-44

MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536.

Product: Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg

Variants: 30-count bottles, 90-count bottles, 1000-count bottles

Lot Numbers:

BLL2107B (Exp 05/2023)

BLL2101A (Exp 01/2025)

BLL2102A (Exp 02/2025)

BLL2103B (Exp 02/2023)

BLL2104A (Exp 05/2023)

NDC:

33342-051-07

33342-051-10

33342-051-44

MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90037

Status: Resolved

Manufacturer: Macleods Pharma Usa Inc

Sold By: Pharmacies nationwide

Manufactured In: United States

Distributed To: Nationwide