Unrated Drug recall · FDA · Published April 15, 2022

Macleods Pharma Losartan Tablets Recall: AZIDO Impurity Risk

Macleods Pharma recalls 50mg Losartan Potassium Tablets due to AZIDO impurity levels exceeding safety limits. Affected lots include BLI2002A through BLI2104B. Contact for return instructions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0833-2022Drug Macleods Pharma ›

Recall notice

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Take action

Contact the company

Recalling firmMacleods Pharma Usa Inc666 Plainsboro Rd Bldg 200 Ste 230 · Plainsboro, NJ 08536-0009

✎ GovInfoNow plain-language explainer

Macleods Pharma is recalling 50mg Losartan Potassium Tablets that may contain unsafe levels of AZIDO impurities. This could pose a health risk if taken by patients. The recall covers specific bottle counts and lot numbers. Read more at govinfonow.com/recall/34825-macleods-pharma-losartan-tablets-recall-azido-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/34825-macleods-pharma-losartan-tablets-recall-azido-impurity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0833-2022

Cite this page

“Macleods Pharma Losartan Tablets Recall: AZIDO Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34825-macleods-pharma-losartan-tablets-recall-azido-impurity-risk. Based on FDA recall #D-0833-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0833-2022%22&limit=1).

The FDA announced on April 15, 2022, that Macleods Pharma USA Inc. is recalling Losartan Potassium Tablets, USP, 50 mg due to azido impurity levels exceeding acceptable limits. The recall affects lots BLI2002A, BLI2004A, and BLI2104B distributed nationwide.

How to tell if you have it

Brand: Macleods Pharma
Product: Losartan Potassium Tablets, USP, 50 mg
NDC # 33342-045-07 (30-count bottles)
NDC # 33342-045-10 (90-count bottles)
NDC # 33342-045-44 (1000-count bottles)
Lot # BLI2002A, exp. date 11/2022
Lot # BLI2004A, exp. date 11/2022
Lot # BLI2104B, exp. date 05/2023

The hazard

The recall is classified as Class II due to Current Good Manufacturing Practice (CGMP) deviations where azido impurity levels were observed to be above acceptable limits.

Context

GovInfoNow's records show Macleods Pharma USA, Inc. has 20 other recalls on record since December 24, 2015. Other recent recalls of similar products include Macleods Levothyroxine Tablets Recall (February 26, 2026), Macleods Losartan/HCTZ Recall (May 7, 2024), and Macleods Pharma Levofloxacin Tablets Recall (January 5, 2023). Additional recent recalls include Macleods Olanzapine Tablets 5mg Recall (August 27, 2026), Ajanta Pharma Fluphenazine Tablets Recall (August 25, 2026), and Amneal traMADol 50mg Tablets Recall (March 19, 2026).

How to tell if you have this one

Check for 50mg Losartan Potassium Tablets in 30-count, 90-count, or 1000-count bottles with the NDC numbers listed. The lot numbers include BLI2002A, BLI2004A, and BLI2104B.

Brand
Macleods Pharma
Category
Drug

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Product was distributed nationwide.

Recall number	Product, codes & lots	Quantity	NDC
D-0832-2022	Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536; Lot # BLH2002A, exp. date 11/2022 BLH2003B, exp. date 11/2022 BLH2004A, exp. date 11/2022	12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets	33342-044-10, 33342-044-12, 33342-044-07, 33342-044-44, 33342-045-10, 33342-045-12, 33342-045-07, 33342-045-44, 33342-046-10, 33342-046-12, 33342-046-07, 33342-046-44
D-0833-2022	Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536; Lot # BLI2002A, exp. date 11/2022 BLI2004A, exp. date 11/2022 BLI2104B, exp. date 05/2023	3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets	33342-044-10, 33342-044-12, 33342-044-07, 33342-044-44, 33342-045-10, 33342-045-12, 33342-045-07, 33342-045-44, 33342-046-10, 33342-046-12, 33342-046-07, 33342-046-44
D-0834-2022	Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536; Lot # BLI2107B, exp. date 06/2023 BLI2101A, exp. date 12/2022 BLI2103A, exp. date 12/2022 BLI2105A, exp. date 05/2023	3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets	33342-044-10, 33342-044-12, 33342-044-07, 33342-044-44, 33342-045-10, 33342-045-12, 33342-045-07, 33342-045-44, 33342-046-10, 33342-046-12, 33342-046-07, 33342-046-44
D-0835-2022	Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536; Lot # BLK2107B, exp. date 05/2023 BLK2101A, exp. date 01/2025 BLK2102A, exp. date 02/2025 BLK2103B, exp. date 02/2023 BLK2103C, exp. date 02/2023 BLK2104A, exp. date 05/2023	N/A	33342-050-07, 33342-050-10, 33342-050-44, 33342-050-12, 33342-051-07, 33342-051-10, 33342-051-44, 33342-051-12, 33342-052-07, 33342-052-10, 33342-052-44, 33342-052-12
D-0836-2022	Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536; Lot # BLM2106B, exp. date 05/2023 BLM2101A, exp. date 01/2025 BLM2102A, exp. date 02/2023 BLM2106A, exp. date 05/2023 BLM2103B, exp. date 02/2023 BLM2104A, exp. date 05/2023 BLM2110A, exp. date 06/2023	N/A	33342-050-07, 33342-050-10, 33342-050-44, 33342-050-12, 33342-051-07, 33342-051-10, 33342-051-44, 33342-051-12, 33342-052-07, 33342-052-10, 33342-052-44, 33342-052-12
D-0837-2022	Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536; Lot # BLL2107B, exp. date 05/2023 BLL2101A, exp. date 01/2025 BLL2102A, exp. date 02/2025 BLL2103B, exp. date 02/2023 BLL2104A, exp. date 05/2023	N/A	33342-050-07, 33342-050-10, 33342-050-44, 33342-050-12, 33342-051-07, 33342-051-10, 33342-051-44, 33342-051-12, 33342-052-07, 33342-052-10, 33342-052-44, 33342-052-12

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the NDC numbers and lot numbers on your medication bottle to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Product was distributed nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

Apr 15, 2022Firm started the recall
May 3, 2022FDA classified it Class II
May 11, 2022Published in FDA’s Enforcement Report
Oct 13, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this medication safe to take?

The recall indicates potential unsafe levels of AZIDO impurities, so it is not safe to take without confirming it is not recalled.

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Other Macleods Pharma recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/34825-macleods-pharma-losartan-tablets-recall-azido-impurity-risk">Macleods Pharma Losartan Tablets Recall: AZIDO Impurity Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0833-2022 (April 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0833-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.