The Recall Desk
HighFDA (Drugs)·D-0840-2022·Announced 2022-05-11

Losartan Potassium tablets recalled for manufacturing impurity above limits

Lupin Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits. Approximately 1,247,067 bottles were affected.

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 of a prescription medication without reported illnesses or hospitalizations. The hazard is a manufacturing quality issue (AZIDO impurity above limits) representing a risk of harm, but no actual injuries have been documented.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Losartan Potassium Tablets USP, 100 mg, due to Current Good Manufacturing Practice (CGMP) deviations. Testing identified AZIDO impurity levels in affected batches that exceed acceptable manufacturing limits.

The recall covers approximately 1,247,067 bottles distributed nationwide in both 90-count and 1,000-count package sizes, with expiration dates ranging from October 2022 through March 2023. Affected bottles are identified by lot codes including H903573, H002311, H100713, and others with corresponding expiration dates.

Patients currently taking affected tablets should contact their pharmacist or healthcare provider to verify their medication is included in this recall and discuss any appropriate next steps or alternative medications.

The recalled product

Product
LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Brand
LOSARTAN POTASSIUM
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug
Hazard
Affected units
1,247,067

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 (20)

  • H903573
  • exp. date Oct-22 H002311
  • exp. date Dec-22 H100713
  • exp. date Mar-23 H001060
  • exp. date Nov-22 H002620
  • exp. date Jan-23 H100714
  • exp. date Mar-23 H001456
  • exp. date Nov-22 H002313
  • exp. date Jan-23 H100934
  • exp. date Mar-23 H001457
  • exp. date Nov-22 H002490
  • exp. date Jan-23 H100935
  • exp. date Mar-23 H001470
  • exp. date Nov-22 H002842
  • exp. date Jan-23 H101081
  • exp. date Mar-23 H001484
  • exp. date Dec-22 H002843
  • exp. date Jan-23 H101148
  • exp. date Mar-23 H001485
  • exp. date Dec-22 H002995

UPCs (9)

  • 0368180212065
  • 0368180376033
  • 0368180210061
  • 0368180378037
  • 0368180308027
  • 0368180376095
  • 0368180211068
  • 0368180309024
  • 0368180377030

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Lupin 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 6 products in this recall →

Related recalls

Same brand · LOSARTAN POTASSIUM

Same manufacturer · Lupin Pharmaceuticals Inc.

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Same hazard · manufacturing defect

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