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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lupin Losartan Potassium Tablets Recalled for Excessive AZIDO Impurities

Agency Publication Date: May 3, 2022
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Summary

Lupin Pharmaceuticals Inc. is recalling 7,250,189 bottles of Losartan Potassium (losartan) and Losartan Potassium and Hydrochlorothiazide (losartan/hydrochlorothiazide) tablets. This prescription blood pressure medication is being recalled because certain batches were found to contain levels of an impurity known as "AZIDO" that exceed the FDA's acceptable safety limits. The recalled tablets were manufactured in India and distributed nationwide to pharmacies and distributors between 2020 and 2022.

Risk

Long-term exposure to AZIDO impurities above acceptable levels may pose a risk to patient health. While no adverse events or injuries have been reported in connection with this specific recall, the impurity levels observed violated Good Manufacturing Practice (GMP) standards.

What You Should Do

  1. This recall affects Losartan Potassium and Losartan Potassium and Hydrochlorothiazide tablets in various strengths (25 mg, 50 mg, and 100 mg) sold in 30, 90, and 1000-count bottles under the Lupin brand.
  2. Check the medication bottle for National Drug Codes (NDC) beginning with 68180 and lot numbers including H001333, H903720, H001149, and many others. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist for guidance. Return any unused product to the place of purchase for a refund, throw it away, or contact Lupin Pharmaceuticals Inc. directly at 1-800-399-2561 for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Losartan Potassium Tablets USP, 25 mg
Variants: 25 mg, Tablet
Lot Numbers (55):
H001333 (Exp Nov-22)
H002786 (Exp Jan-23)
H101282 (Exp Feb-23)
H001189 (Exp Nov-22)
H002955 (Exp Jan-23)
H101285 (Exp Feb-23)
H001714 (Exp Dec-22)
H000523 (Exp Jan-23)
H101989 (Exp Mar-23)
H001940 (Exp Dec-22)
H003080 (Exp Jan-23)
H101789 (Exp Mar-23)
H002388 (Exp Jan-23)
H100109 (Exp Feb-23)
H002389 (Exp Jan-23)
H100642 (Exp Feb-23)
H000848 (Exp Nov-22)
H002002 (Exp Dec-22)
H100110 (Exp Feb-23)
H001190 (Exp Nov-22)
H002003 (Exp Dec-22)
H100111 (Exp Feb-23)
H001191 (Exp Nov-22)
H002489 (Exp Jan-23)
H100146 (Exp Feb-23)
H001192 (Exp Nov-22)
H002390 (Exp Jan-23)
H100147 (Exp Feb-23)
H001058 (Exp Nov-22)
H002486 (Exp Jan-23)
H101283 (Exp Feb-23)
H000985 (Exp Nov-22)
H002487 (Exp Jan-23)
H101284 (Exp Feb-23)
H001059 (Exp Nov-22)
H002488 (Exp Jan-23)
H100643 (Exp Feb-23)
H001275 (Exp Nov-22)
H002787 (Exp Jan-23)
H100644 (Exp Mar-23)
H001715 (Exp Dec-22)
H002957 (Exp Jan-23)
H100869 (Exp Mar-23)
H001716 (Exp Dec-22)
H002958 (Exp Jan-23)
H101990 (Exp Mar-23)
H001717 (Exp Dec-22)
H003079 (Exp Jan-23)
H101991 (Exp Mar-23)
H001718 (Exp Dec-22)
NDC:
68180-376-03
68180-376-09

Available in 90-count and 1000-count bottles.

Product: Losartan Potassium Tablets USP, 50 mg
Variants: 50 mg, Tablet
Lot Numbers:
H903720 (Exp Oct-22)
H001876 (Exp Dec-22)
H003002 (Exp Jan-23)
H903774 (Exp Oct-22)
H001877 (Exp Dec-22)
H003003 (Exp Feb-23)
H000849 (Exp Nov-22)
H002127 (Exp Dec-22)
H003004 (Exp Feb-23)
H001412 (Exp Nov-22)
H002128 (Exp Dec-22)
H003123 (Exp Feb-23)
H001413 (Exp Nov-22)
H002643 (Exp Jan-23)
H003124 (Exp Feb-23)
H001414 (Exp Nov-22)
H002644 (Exp Jan-23)
H101129 (Exp Feb-23)
H001430 (Exp Nov-22)
H002645 (Exp Jan-23)
H101147 (Exp Mar-23)
H001526 (Exp Dec-22)
H002839 (Exp Jan-23)
H102139 (Exp Mar-23)
H001652 (Exp Dec-22)
H002840 (Exp Jan-23)
H102158 (Exp Mar-23)
H000605 (Exp Jan-23)
H001599 (Exp Dec-22)
H100148 (Exp Feb-23)
H001401 (Exp Nov-22)
H001875 (Exp Dec-22)
H102043 (Exp Mar-23)
H001063 (Exp Nov-22)
H002126 (Exp Dec-22)
H101495 (Exp Mar-23)
H001188 (Exp Nov-22)
H002838 (Exp Jan-23)
H001455 (Exp Nov-22)
H002642 (Exp Jan-23)
NDC:
68180-377-03
68180-377-09

Available in 90-count and 1000-count bottles.

Product: Losartan Potassium Tablets USP, 100 mg
Variants: 100 mg, Tablet
Lot Numbers (61):
H903573 (Exp Oct-22)
H002311 (Exp Dec-22)
H100713 (Exp Mar-23)
H001060 (Exp Nov-22)
H002620 (Exp Jan-23)
H100714 (Exp Mar-23)
H001456 (Exp Nov-22)
H002313 (Exp Jan-23)
H100934 (Exp Mar-23)
H001457 (Exp Nov-22)
H002490 (Exp Jan-23)
H100935 (Exp Mar-23)
H001470 (Exp Nov-22)
H002842 (Exp Jan-23)
H101081 (Exp Mar-23)
H001484 (Exp Dec-22)
H002843 (Exp Jan-23)
H101148 (Exp Mar-23)
H001485 (Exp Dec-22)
H002995 (Exp Jan-23)
H101639 (Exp Mar-23)
H001708 (Exp Dec-22)
H003199 (Exp Feb-23)
H101480 (Exp Mar-23)
H002314 (Exp Dec-22)
H003200 (Exp Feb-23)
H101822 (Exp Mar-23)
H001709 (Exp Dec-22)
H100028 (Exp Feb-23)
H101481 (Exp Mar-23)
H002001 (Exp Dec-22)
H100712 (Exp Feb-23)
H102288 (Exp Mar-23)
H001991 (Exp Dec-22)
H100221 (Exp Feb-23)
H002000 (Exp Dec-22)
H100222 (Exp Feb-23)
H903582 (Exp Oct-22)
H001707 (Exp Dec-22)
H100220 (Exp Feb-23)
H000556 (Exp Nov-22)
H003045 (Exp Dec-22)
H100901 (Exp Mar-23)
H000557 (Exp Nov-22)
H002391 (Exp Dec-22)
H101078 (Exp Mar-23)
H001061 (Exp Nov-22)
H002312 (Exp Jan-23)
H101479 (Exp Mar-23)
H001062 (Exp Nov-22)
NDC:
68180-378-03
68180-378-09

Available in 90-count and 1000-count bottles.

Product: Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg
Variants: 50 mg / 12.5 mg, Tablet
Lot Numbers (83):
H001149 (Exp 4/30/2022)
H001602 (Exp 5/31/2022)
H001884 (Exp 6/30/2022)
H002539 (Exp 8/31/2022)
H100944 (Exp 4/30/2023)
H101054 (Exp 4/30/2023)
H001150 (Exp 4/30/2022)
H001151 (Exp 4/30/2022)
H001152 (Exp 4/30/2022)
H001532 (Exp 5/31/2022)
H001533 (Exp 5/31/2022)
H001534 (Exp 5/31/2022)
H001535 (Exp 5/31/2022)
H001536 (Exp 5/31/2022)
H001603 (Exp 5/31/2022)
H001604 (Exp 5/31/2022)
H001605 (Exp 5/31/2022)
H001606 (Exp 5/31/2022)
H001607 (Exp 5/31/2022)
H001608 (Exp 5/31/2022)
H001885 (Exp 6/30/2022)
H001886 (Exp 6/30/2022)
H001887 (Exp 6/30/2022)
H001888 (Exp 6/30/2022)
H002171 (Exp 7/31/2022)
H002172 (Exp 7/31/2022)
H002173 (Exp 7/31/2022)
H002174 (Exp 7/31/2022)
H002175 (Exp 7/31/2022)
H002540 (Exp 8/31/2022)
H002541 (Exp 8/31/2022)
H002542 (Exp 8/31/2022)
H002543 (Exp 8/31/2022)
H002544 (Exp 8/31/2022)
H002545 (Exp 8/31/2022)
H002976 (Exp 10/31/2022)
H002977 (Exp 10/31/2022)
H002978 (Exp 10/31/2022)
H003131 (Exp 11/30/2022)
H003132 (Exp 11/30/2022)
H003133 (Exp 11/30/2022)
H003134 (Exp 11/30/2022)
H003135 (Exp 11/30/2022)
H003136 (Exp 11/30/2022)
H100302 (Exp 1/31/2023)
H100303 (Exp 1/31/2023)
H100304 (Exp 1/31/2023)
H100340 (Exp 1/31/2023)
H100341 (Exp 1/31/2023)
H100657 (Exp 2/28/2023)
NDC:
68180-215-06
68180-215-09

Available in 30-count and 90-count bottles.

Product: Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg
Variants: 100 mg / 25 mg, Tablet
Lot Numbers (143):
H001156 (Exp 4/30/2022)
H001627 (Exp 5/31/2022)
H001947 (Exp 6/30/2022)
H002242 (Exp 8/31/2022)
H101826 (Exp 7/31/2023)
H001155 (Exp 4/30/2022)
H001355 (Exp 5/31/2022)
H001356 (Exp 5/31/2022)
H001357 (Exp 5/31/2022)
H001358 (Exp 5/31/2022)
H001359 (Exp 5/31/2022)
H001371 (Exp 5/31/2022)
H001372 (Exp 5/31/2022)
H001373 (Exp 5/31/2022)
H001374 (Exp 5/31/2022)
H001375 (Exp 5/31/2022)
H001628 (Exp 5/31/2022)
H001629 (Exp 5/31/2022)
H001630 (Exp 6/30/2022)
H001645 (Exp 6/30/2022)
H001646 (Exp 6/30/2022)
H001647 (Exp 6/30/2022)
H001798 (Exp 6/30/2022)
H001799 (Exp 6/30/2022)
H001882 (Exp 6/30/2022)
H001883 (Exp 6/30/2022)
H001948 (Exp 6/30/2022)
H001949 (Exp 6/30/2022)
H001985 (Exp 6/30/2022)
H001986 (Exp 6/30/2022)
H001987 (Exp 7/31/2022)
H001988 (Exp 7/31/2022)
H001989 (Exp 7/31/2022)
H001990 (Exp 7/31/2022)
H002243 (Exp 8/31/2022)
H002244 (Exp 8/31/2022)
H002245 (Exp 8/31/2022)
H002315 (Exp 8/31/2022)
H002316 (Exp 8/31/2022)
H002317 (Exp 8/31/2022)
H002318 (Exp 8/31/2022)
H002319 (Exp 8/31/2022)
H002320 (Exp 8/31/2022)
H002321 (Exp 8/31/2022)
H002322 (Exp 8/31/2022)
H002323 (Exp 8/31/2022)
H002324 (Exp 8/31/2022)
H002632 (Exp 9/30/2022)
H002633 (Exp 9/30/2022)
H002634 (Exp 9/30/2022)
NDC:
68180-217-06
68180-217-09

Available in 30-count and 90-count bottles.

Product: Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg
Variants: 100 mg / 12.5 mg, Tablet
Lot Numbers (96):
H001878 (Exp 6/30/2022)
H002178 (Exp 7/31/2022)
H002626 (Exp 9/30/2022)
H102149 (Exp 9/30/2023)
H001600 (Exp 5/31/2022)
H001601 (Exp 5/1/2022)
H001625 (Exp 5/31/2022)
H001626 (Exp 5/31/2022)
H001794 (Exp 6/30/2022)
H001795 (Exp 6/30/2022)
H001796 (Exp 6/30/2022)
H001797 (Exp 6/30/2022)
H001879 (Exp 6/30/2022)
H001880 (Exp 6/30/2022)
H001881 (Exp 6/30/2022)
H001942 (Exp 6/30/2022)
H001943 (Exp 6/30/2022)
H001944 (Exp 6/30/2022)
H001945 (Exp 6/30/2022)
H001946 (Exp 6/30/2022)
H002179 (Exp 7/31/2022)
H002180 (Exp 7/31/2022)
H002181 (Exp 8/31/2022)
H002182 (Exp 8/31/2022)
H002183 (Exp 8/31/2022)
H002237 (Exp 8/31/2022)
H002238 (Exp 8/31/2022)
H002239 (Exp 8/31/2022)
H002240 (Exp 8/31/2022)
H002241 (Exp 8/31/2022)
H002627 (Exp 9/30/2022)
H002628 (Exp 9/30/2022)
H002629 (Exp 9/30/2022)
H002630 (Exp 9/30/2022)
H002631 (Exp 9/30/2022)
H002979 (Exp 11/30/2022)
H002980 (Exp 11/30/2022)
H002981 (Exp 11/30/2022)
H002982 (Exp 11/30/2022)
H002983 (Exp 11/30/2022)
H100112 (Exp 12/31/2022)
H100113 (Exp 12/31/2022)
H100114 (Exp 12/31/2022)
H100115 (Exp 12/31/2022)
H100116 (Exp 12/31/2022)
H100156 (Exp 12/31/2022)
H100157 (Exp 12/31/2022)
H100622 (Exp 2/28/2023)
H100623 (Exp 2/28/2023)
H100624 (Exp 2/28/2023)
NDC:
68180-216-06
68180-216-09

Available in 30-count and 90-count bottles.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89916
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: pharmacies
Manufactured In: India
Units Affected: 6 products (657,336 bottles; 1,466,150 bottles; 1,247,067 bottles; 1,214,016 bottles; 303,696 bottles; 2,361,924 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.