Reported May 11, 2022 · Terminated

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b)…

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 and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only
  • Manufactured ByLupin Limited, Pithampur, India
  • MFG ForLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
Lot codes and dates
  • Lot #

    288 of 288 codes

    • H001878
    • 6/30/2022
    • 68180-216-06
    • H002178
    • 7/31/2022
    • 68180-216-06
    • H002626
    • 9/30/2022
    • 68180-216-06
    • H102149
    • 9/30/2023
    • 68180-216-06
    • H001600
    • 5/31/2022
    • 68180-216-09
    • H001601
    • 5/1/2022
    • 68180-216-09
    • H001625
    • 5/31/2022
    • 68180-216-09
    • H001626
    • 5/31/2022
    • 68180-216-09
    • H001794
    • 6/30/2022
    • 68180-216-09
    • H001795
    • 6/30/2022
    • 68180-216-09
    • H001796
    • 6/30/2022
    • 68180-216-09
    • H001797
    • 6/30/2022
    • 68180-216-09
    • H001879
    • 6/30/2022
    • 68180-216-09
    • H001880
    • 6/30/2022
    • 68180-216-09
    • H001881
    • 6/30/2022
    • 68180-216-09
    • H001942
    • 6/30/2022
    • 68180-216-09
    • H001943
    • 6/30/2022
    • 68180-216-09
    • H001944
    • 6/30/2022
    • 68180-216-09
    • H001945
    • 6/30/2022
    • 68180-216-09
    • H001946
    • 6/30/2022
    • 68180-216-09
Amount recalled
2,361,924 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, 5:54 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.