Reported May 11, 2022 · Terminated

Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC#…

Lupin Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lupin Pharmaceuticals Inc. · Harborplace Tower · Baltimore, MD · 21202-6174

Is this the product you have?

    • Losartan Potassium Tablets USP
    • 50 mg
    • a) 90-count bottles (NDC# 68180-377-03)
    • b) 1000-count bottles (NDC# 68180-377-09)
    • Rx Only
  • Manufactured ByLupin Limited, Pithampur, India
  • MFG ForLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
Lot codes and dates
    • 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
    • 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
Amount recalled
1,466,150 bottles

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 22, 2023 · Data as of Sep 19, 5:05 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.