The Recall Desk
HighFDA (Drugs)·D-0839-2022·Announced 2022-05-11

Losartan Potassium Tablets Recalled Due to Unacceptable Chemical Impurity Levels

Lupin Pharmaceuticals is recalling 1.47 million bottles of Losartan Potassium Tablets due to chemical impurities exceeding acceptable limits. The affected batches 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 involving manufacturing deviations where AZIDO impurity levels exceeded acceptable limits. Meets the High severity criterion as a risk-of-harm product with no reported illnesses or injuries to date.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Losartan Potassium Tablets USP 50 mg. The affected product includes both 90-count and 1000-count bottles distributed nationwide. Approximately 1.47 million bottles with various lot codes and expiration dates from November 2022 through March 2023 are included in the recall.

The recall was issued due to a manufacturing quality deviation. AZIDO impurity levels were observed to exceed acceptable limits, which constitutes a Current Good Manufacturing Practice (cGMP) violation. The FDA classified this as a Class II recall.

Consumers and healthcare providers with affected batches should identify the specific lot codes and expiration dates listed in the FDA recall notice. Patients currently taking Losartan Potassium should consult with their healthcare provider or pharmacist regarding their medication and whether their prescription is affected. Lupin Pharmaceuticals Inc. can provide additional information about specific batches.

The recalled product

Product
LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Brand
LOSARTAN POTASSIUM
Manufacturer
Lupin 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 (20)

  • H903720
  • exp. date Oct-22 H001876
  • exp. date Dec-22 H003002
  • exp. date Jan-23 H903774
  • exp. date Oct-22 H001877
  • exp. date Dec-22 H003003
  • exp. date Feb-23 H000849
  • exp. date Nov-22 H002127
  • exp. date Dec-22 H003004
  • exp. date Feb-23 H001412
  • exp. date Nov-22 H002128
  • exp. date Dec-22 H003123
  • exp. date Feb-23 H001413
  • exp. date Nov-22 H002643
  • exp. date Jan-23 H003124
  • exp. date Feb-23 H001414
  • exp. date Nov-22 H002644
  • exp. date Jan-23 H101129
  • exp. date Feb-23 H001430
  • exp. date Nov-22 H002645

UPCs (9)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · LOSARTAN POTASSIUM

Same category