The Recall Desk
HighFDA (Drugs)·D-0835-2022·Announced 2022-05-11

Losartan potassium and hydrochlorothiazide tablets recalled for manufacturing quality deviations

Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets due to manufacturing quality issues with chemical impurity levels above acceptable limits. Affected lots were distributed nationwide in 30-, 90-, and 1000-count bottles.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall triggered by CGMP deviations with AZIDO impurity levels exceeding acceptable pharmaceutical standards. No illnesses or injuries have been reported, but exceeding established purity limits represents a potential product safety concern.

Plain-English summary

Macleods Pharma USA Inc is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg. The product is available in 30-count, 90-count, and 1000-count bottles and is a prescription antihypertensive medication used to treat high blood pressure.

The recall was issued due to Current Good Manufacturing Practice (CGMP) deviations. Testing identified that AZIDO impurity levels in affected lots exceeded acceptable manufacturing standards.

The affected lot numbers are: BLK2107B (expiration 05/2023), BLK2101A (expiration 01/2025), BLK2102A (expiration 02/2025), BLK2103B (expiration 02/2023), BLK2103C (expiration 02/2023), and BLK2104A (expiration 05/2023). The product was distributed nationwide.

Consumers with an affected lot should verify the lot number on their medication bottle against the list above to determine if their product is included in this recall.

The recalled product

Product
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
Brand
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Manufacturer
Macleods Pharma Usa Inc
Category
Drug — Prescription Antihypertensive
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • 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

UPCs (7)

  • 0333342051448
  • 0333342050106
  • 0333342052100
  • 0333342051103
  • 0333342052445
  • 0333342051073
  • 0333342052070

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Macleods Pharma Usa Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same brand · LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Same manufacturer · Macleods Pharma Usa Inc

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Same hazard · manufacturing deviation

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