The Recall Desk
HighFDA (Drugs)·D-0838-2022·Announced 2022-05-11

Losartan Potassium tablets recalled for AZIDO impurity above limits

Lupin Pharmaceuticals recalls Losartan Potassium tablets for CGMP deviations with AZIDO impurity above limits. The recall affects 657,336 bottles distributed nationwide; no illnesses reported.

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 drug recall involving CGMP deviations and chemical impurity above acceptable limits in a prescription medication. No illnesses or adverse events reported. Qualifies as risk-of-harm product where injury has not yet been reported.

Plain-English summary

Lupin Pharmaceuticals is recalling Losartan Potassium Tablets USP 25 mg due to manufacturing quality control issues. The recall affects 657,336 bottles (90-count and 1000-count bottles) distributed nationwide that were manufactured by Lupin Limited in Pithampur, India for Lupin Pharmaceuticals in Baltimore, Maryland.

The recall is prompted by Current Good Manufacturing Practice (CGMP) deviations. Laboratory testing found AZIDO impurity levels above acceptable limits in multiple batches of the medication. Affected batches have expiration dates ranging from November 2022 to March 2023.

Patients currently taking Losartan Potassium should consult their pharmacist or healthcare provider about their specific medication to determine if it is part of the recall. Do not discontinue the medication without medical guidance. Check your bottle's batch code and expiration date against the recall list.

No illnesses or adverse events have been reported to the FDA at this time.

The recalled product

Product
LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
Brand
LOSARTAN POTASSIUM
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug
Hazard
Affected units
657,336

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)

  • H001333
  • exp. date Nov-22 H002786
  • exp. date Jan-23 H101282
  • exp. date Feb-23 H001189
  • exp. date Nov-22 H002955
  • exp. date Jan-23 H101285
  • exp. date Feb-23 H001714
  • exp. date Dec-22 H000523
  • exp. date Jan-23 H101989
  • exp. date Mar-23 H001940
  • exp. date Dec-22 H003080
  • exp. date Jan-23 H101789
  • exp. date Mar-23 H002388
  • exp. date Jan-23 H100109
  • exp. date Feb-23 H002389
  • exp. date Jan-23 H100642
  • exp. date Feb-23 H000848
  • exp. date Nov-22
  • H002002
  • exp. date Dec-22 H100110

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 →

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Same brand · LOSARTAN POTASSIUM

Same manufacturer · Lupin Pharmaceuticals Inc.

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Same hazard · chemical impurity

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