The Recall Desk
HighFDA (Drugs)·D-1163-2022·Announced 2022-07-06

Losartan Potassium Tablets Recalled for Elevated AZIDO Impurity Levels

PD-Rx Pharmaceuticals is recalling Losartan Potassium 100 mg tablets due to AZIDO impurity levels above acceptable limits detected during manufacturing. Approximately 1,320 bottles were distributed nationwide.

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 of a prescription drug with confirmed manufacturing impurity deviation. No illnesses, injuries, or deaths are reported in the source text. Per rubric criteria, confirmed hazards in risk-of-harm products without reported harm qualify as High severity.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling Losartan Potassium Tablets, USP 100 mg. The recall affects approximately 1,320 bottles with specific lot numbers that were distributed nationwide.

The recall is due to a manufacturing quality deviation. Testing identified AZIDO impurity levels that exceeded acceptable limits in certain lots, representing a deviation from FDA Current Good Manufacturing Practice (CGMP) standards.

The affected lot numbers and expiration dates are: G21C26 (expires 07/31/22), H21B96 (expires 07/31/22), I21B39 (expires 07/31/22), I21C44 (expires 07/31/22), D21F35 (expires 10/31/22), E21A66 (expires 10/31/22), E21C72 (expires 10/31/22), E21F01 (expires 10/31/22), F21C15 (expires 10/31/22), F21E19 (expires 10/31/22), G21B14 (expires 10/31/22), K21A61 (expires 11/30/22), and L21A45 (expires 11/30/22). Consumers with affected tablets should consult their healthcare provider or pharmacist about alternative medications. Do not discontinue blood pressure medication without medical guidance.

The recalled product

Product
LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Brand
LOSARTAN POTASSIUM
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Category
Drug
Hazard
  • azido-impurity
  • manufacturing-defect

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 (13)

  • Lots: G21C26 Exp. 07/31/22
  • H21B96 Exp. 07/31/22
  • I21B39 Exp. 07/31/22
  • I21C44 Exp. 07/31/22
  • D21F35 Exp. 10/31/22
  • E21A66 Exp. 10/31/22
  • E21C72 Exp. 10/31/22
  • E21F01 Exp. 10/31/22
  • F21C15 Exp. 10/31/22
  • F21E19 Exp. 10/31/22
  • G21B14 Exp. 10/31/22
  • K21A61 Exp. 11/30/22
  • L21A45 Exp. 11/30/22

UPCs (4)

  • 0372789163901
  • 0372789164908
  • 0372789165905
  • 372789165905

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · LOSARTAN POTASSIUM

Same category