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Class II · ModerateRecall completed

Losartan Potassium

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberH903720, 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, exp. date Jan-23 H101147, exp. date Mar-23 H001526, exp. date Dec-22 H002839, exp. date Jan-23 H102139, exp. date Mar-23 H001652, exp. date Dec-22 H002840, exp. date Jan-23 H102158, exp. date Mar-23 H000605, exp. date Jan-23 H001599, exp. date Dec-22 H100148, exp. date Feb-23 H001401, exp. date Nov-22 H001875, exp. date Dec-22 H102043, exp. date Mar-23 H001063, exp. date Nov-22 H002126, exp. date Dec-22 H101495, exp. date Mar-23 H001188, exp. date Nov-22 H002838, exp. date Jan-23 H001455, exp. date Nov-22 H002642, exp. date Jan-23
Where it was soldProduct was distributed nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byLupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA foreign manufacturer
Brand nameLOSARTAN POTASSIUM
Generic nameLOSARTAN POTASSIUM
Active ingredient(s)LOSARTAN POTASSIUM
Distributed by / forLupin Pharmaceuticals Inc.
NDC68180-377-03
Show the full FDA record
Full product labelLosartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct was distributed nationwide
Quantity1,466,150 bottles
Recall initiated2022-03-31
Report date2022-05-11
Recall completed2023-05-22
Recall numberD-0839-2022
ClassificationClass II
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

Losartan recallsRecent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.