The Recall Desk
HighFDA (Drugs)·D-0891-2022·Announced 2022-06-01

Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Elevated Azido Impurity

Preferred Pharmaceuticals recalls Losartan Potassium & HCTZ Tablets (50mg/12.5mg) in Florida and California due to elevated azido impurity levels above acceptable manufacturing limits.

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 pharmaceutical recall with CGMP deviations and elevated impurity levels above acceptable limits. No reported illnesses or hospitalizations qualify this as a risk-of-harm product without confirmed injury.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Losartan Potassium & HCTZ Tablets 50mg/12.5mg (NDC 68788-7758-09) due to Current Good Manufacturing Practice (CGMP) deviations. The affected lots are K1721D (expiration 4/30/2023) with 31 bottles and K1021E (expiration 7/31/2023) with 5 bottles.

The recall was initiated because azido impurity levels in these lots were observed to be above acceptable limits. These impurities were identified during manufacturing quality testing.

The affected products were distributed in Florida and California only. Patients taking these medications should consult with their healthcare provider or pharmacist regarding the recall.

Consumers who have purchased these products should contact their pharmacy or Preferred Pharmaceuticals, Inc. for instructions on return or disposal.

The recalled product

Product
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug — Blood Pressure Medication
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 (6)

  • Lot: K1721D
  • EXP: 4/30/2023
  • NDC: 68788-7758-09
  • Lot: K1021E
  • EXP: 7/31/2023
  • NDC: 68788-7758-09.

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 2 recalled by Preferred Pharmaceuticals, 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 2 products in this recall →

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