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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

Golden State Medical Supply Inc.: Losartan Potassium Tablets Recalled for Excessive Impurity (NMBA)

Agency Publication Date: May 19, 2019
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Summary

Golden State Medical Supply Inc. has recalled approximately 234,296 bottles of Losartan Potassium (25 mg and 100 mg), a medication used to treat high blood pressure. Testing confirmed that the tablets contain an impurity called N-Methylnitrosobutyric acid (NMBA) at levels higher than what the FDA considers acceptable for daily intake. These products were distributed to various healthcare accounts in several states and government facilities.

Risk

NMBA is a suspected human carcinogen, meaning long-term exposure to levels above the interim acceptable daily intake could potentially increase the risk of cancer. While no immediate health issues have been reported, the levels found in these specific batches exceeded safety guidelines set by the manufacturer.

What You Should Do

  1. Check your medication bottle for Losartan Potassium Tablets USP 25 mg or 100 mg from GSMS Incorporated.
  2. Verify if your bottle matches the following NDC and lot numbers: for 25 mg (30-ct) NDC 60429-316-30 lots GS017981, GS016958, GS017341; (90-ct) NDC 60429-316-90 lots GS015172, GS017634, GS017653, GS017980, GS017276, GS017045, GS016726; (1000-ct) NDC 60429-316-10 lots GS015204, GS018318, GS014817, GS017342, GS017808.
  3. For 100 mg tablets, check (90-ct) NDC 60429-318-90 lots GS014045, GS014305, GS014044, GS016535, GS016524, GS017384, GS017385, GS017539, GS017540, GS017543, GS017542, GS017984, GS017985, GS017986, GS018263, GS018264, GS018265; or (1000-ct) NDC 60429-318-10 lots GS014054, GS016338, GS016341, GS016342, GS016343, GS016344, GS016345, GS016539, GS016969, GS016973, GS017337, GS018524.
  4. Do NOT stop taking your medication before talking to your doctor or pharmacist, as the risk of harm to your health may be higher if the treatment is stopped suddenly without an alternative.
  5. Contact your healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
  6. Return any unused product from the affected lots to your pharmacy for a refund and contact Golden State Medical Supply Inc. at 1-888-723-3332 for further instructions.
  7. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Losartan Potassium Tablets USP 25 mg (30 count bottle)
Model:
NDC 60429-316-30
Recall #: D-1282-2019
Lot Numbers:
GS017981
GS016958
GS017341
Date Ranges: exp 02/2020
Product: Losartan Potassium Tablets USP 25 mg (90 count bottle)
Model:
NDC 60429-316-90
Recall #: D-1283-2019
Lot Numbers:
GS015172
GS017634
GS017653
GS017980
GS017276
GS017045
GS016726
Date Ranges: exp 06/2019, exp 02/2020
Product: Losartan Potassium Tablets USP 25 mg (1000 count bottle)
Model:
NDC 60429-316-10
Recall #: D-1284-2019
Lot Numbers:
GS015204
GS018318
GS014817
GS017342
GS017808
Date Ranges: exp 06/2019, exp 02/2020
Product: Losartan Potassium Tablets USP 100 mg (90 count bottle)
Model:
NDC 60429-318-90
Recall #: D-1285-2019
Lot Numbers:
GS014045
GS014305
GS014044
GS016535
GS016524
GS017384
GS017385
GS017539
GS017540
GS017543
GS017542
GS017984
GS017985
GS017986
GS018263
GS018264
GS018265
Date Ranges: exp 06/2019, exp 01/2020, exp 02/2020
Product: Losartan Potassium Tablets USP 100 mg (1000 count bottle)
Model:
NDC 60429-318-10
Recall #: D-1286-2019
Lot Numbers:
GS014054
GS016338
GS016341
GS016342
GS016343
GS016344
GS016345
GS016539
GS016969
GS016973
GS017337
GS018524
Date Ranges: exp 06/2019, exp 12/2019, exp 01/2020, exp 02/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82832
Status: Resolved
Manufacturer: Golden State Medical Supply Inc.
Sold By: US Government accounts; Veterans Affairs accounts
Manufactured In: United States
Units Affected: 5 products (11,668 HDPE bottles; 64,362 HDPE bottles; 11,286 HDPE Bottles; 138,213 HDPE Bottles; 8,767 HDPE Bottles)
Distributed To: Illinois, Michigan, Minnesota, Pennsylvania, Tennessee, Texas

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.