Macleods Pharma Losartan potassium & Hydrochlorothiazide Recall

Why it was recalled

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

Product description

Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

Lot numbers, UPCs & expiration codes

Lot # BLM2114A, exp. date 07/2023

Where it was sold

Product was distributed nationwide.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1164-2022
Classification: Class II
Status: Terminated
Recall initiated: Jun 10, 2022
FDA report date: Jul 6, 2022
Quantity: 84/1000 count bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Macleods Pharma Usa Inc

Original FDA data

Every field from FDA enforcement report D-1164-2022, exactly as published.

Show all FDA fields

City: Plainsboro
State: NJ
Status: Terminated
Country: United States
Event ID: 90426
Address: 666 Plainsboro Rd Bldg 200 Ste 230
Code information: Lot # BLM2114A, exp. date 07/2023
Postal code: 08536-0009
Report date: Jul 6, 2022
Product type: Drugs
Recall number: D-1164-2022
Classification: Class II
Recalling firm: Macleods Pharma Usa Inc
Product quantity: 84/1000 count bottles
Termination date: May 23, 2024
Reason for recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Voluntary / mandated: Voluntary: Firm initiated
Product description: Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Distribution pattern: Product was distributed nationwide.
Recall initiation date: Jun 10, 2022
Initial firm notification: Letter
Center classification date: Jun 27, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1164-2022, published Jul 6, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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