Reported May 11, 2022 · Terminated

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) 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/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only
  • Manufactured ByLupin Limited, Pithampur, India
  • MFG ForLupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA
Lot codes and dates
  • Lot #

    429 of 429 codes

    • H001156
    • 4/30/2022
    • 68180-217-06
    • H001627
    • 5/31/2022
    • 68180-217-06
    • H001947
    • 6/30/2022
    • 68180-217-06
    • H002242
    • 8/31/2022
    • 68180-217-06
    • H101826
    • 7/31/2023
    • 68180-217-06
    • H001155
    • 4/30/2022
    • 68180-217-09
    • H001355
    • 5/31/2022
    • 68180-217-09
    • H001356
    • 5/31/2022
    • 68180-217-09
    • H001357
    • 5/31/2022
    • 68180-217-09
    • H001358
    • 5/31/2022
    • 68180-217-09
    • H001359
    • 5/31/2022
    • 68180-217-09
    • H001371
    • 5/31/2022
    • 68180-217-09
    • H001372
    • 5/31/2022
    • 68180-217-09
    • H001373
    • 5/31/2022
    • 68180-217-09
    • H001374
    • 5/31/2022
    • 68180-217-09
    • H001375
    • 5/31/2022
    • 68180-217-09
    • H001628
    • 5/31/2022
    • 68180-217-09
    • H001629
    • 5/31/2022
    • 68180-217-09
    • H001630
    • 6/30/2022
    • 68180-217-09
    • H001645
    • 6/30/2022
    • 68180-217-09
Amount recalled
303,696 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, 8:06 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.