The Recall Desk
HighFDA (Drugs)·D-0894-2022·Announced 2022-06-01

Blood Pressure Medication Recalled for Manufacturing Impurity

Direct Rx is recalling batches of Losartan Potassium/Hydrochlorothiazide tablets due to CGMP deviations with elevated AZIDO impurity levels. The affected product was distributed in Florida.

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: This is an FDA Class II recall involving manufacturing deviations with elevated AZIDO impurity levels in a prescription pharmaceutical. While no illnesses or injuries have been reported, impurity above acceptable limits in a medication for chronic disease management constitutes a risk-of-harm product, meeting Score 3 criteria.

Plain-English summary

Direct Rx is recalling multiple batches of Losartan Potassium and Hydrochlorothiazide 50/12.5 mg tablets. The affected product is a combination blood pressure medication distributed in Florida under NDC 72189-297-90. Six bottles are involved in this recall.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. Analysis found that AZIDO impurity levels in affected batches exceeded acceptable limits. Elevated impurity levels in pharmaceutical products can compromise product quality and pose risks to patients who depend on consistent medication efficacy.

The affected lots are: 19NO2108 (expires 1/31/25), 19NO2114 (expires 1/31/25), and 22NO2126 (expires 1/31/25). Patients taking this medication should consult their healthcare provider before making any changes to their treatment. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
Brand
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Manufacturer
Direct Rx
Category
Drug — Blood Pressure Medication
Hazard
Affected units
6

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 (3)

  • Lots: 19NO2108 Exp. 1/31/25
  • 19NO2114 Exp. 1/31/25
  • 22NO2126 Exp. 1/31/25

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Direct Rx 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 3 products in this recall →

Related recalls

Same brand · LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Same manufacturer · Direct Rx

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Same hazard · azido impurity

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