Reported May 11, 2022 · Terminated

Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), 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
    • 100 mg
    • a) 90-count bottles (NDC# 68180-378-03)
    • b) 1000-count bottles (NDC# 68180-378-09)
    • Rx Only
  • Manufactured ByLupin Limited, Pithampur, India
  • MFG ForLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
Lot codes and dates
  • 62 of 62 codes

    • 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
    • exp. date Jan-23 H101639
    • exp. date Mar-23 H001708
    • exp. date Dec-22 H003199
    • exp. date Feb-23 H101480
    • exp. date Mar-23 H002314
    • exp. date Dec-22 H003200
    • exp. date Feb-23 H101822
    • exp. date Mar-23 H001709
    • exp. date Dec-22 H100028
    • exp. date Feb-23 H101481
    • exp. date Mar-23 H002001
    • exp. date Dec-22 H100712
    • exp. date Feb-23 H102288
    • exp. date Mar-23 H001991
    • exp. date Dec-22 H100221
    • exp. date Feb-23 H002000
    • exp. date Dec-22 H100222
    • exp. dateFeb-23 H903582
    • exp. date Oct-22 H001707
    • exp. dateDec-22 H100220
    • exp. date Feb-23 H000556
    • exp. date Nov-22 H003045
    • exp. date Dec-22 H100901
    • exp. date Mar-23 H000557
    • exp. date Nov-22 H002391
    • exp. date Dec-22 H101078
    • exp. date Mar-23 H001061
    • exp. date Nov-22 H002312
    • exp. date Jan-23 H101479
    • exp. date Mar-23 H001062
    • exp. date Nov-22 H002517
    • exp. date Jan-23 H101496
    • exp. date Mar-23 H001431
    • exp. date Nov-22 H002841
    • exp. date Jan-23 H101821
    • exp. date Mar-23 H002341
    • exp. date Nov-22 H003044
    • exp. date Feb-23 H102286
    • exp. date Mar-23 H001706
    • exp. date Dec-22 H003198
Amount recalled
1,247,067 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, 7:20 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.