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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Camber Pharmaceuticals Inc: Losartan Potassium Tablets Recalled for Impurity and CGMP Deviations

Agency Publication Date: March 21, 2019
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Summary

Camber Pharmaceuticals Inc. has recalled approximately 1,105,085 bottles of Losartan Potassium Tablets USP (25 mg, 50 mg, and 100 mg) due to the detection of a chemical impurity called NMBA in the active ingredient. NMBA is a potential human carcinogen that was found during testing, and its presence indicates a deviation from current Good Manufacturing Practices (CGMP). These prescription medications were distributed nationwide in various bottle counts ranging from 30 to 1,000 tablets. Consumers should not stop taking their medication without first consulting a healthcare provider, as the risk of stopping high blood pressure treatment may be greater than the risk of the impurity.

Risk

The tablets contain trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), which is classified as a potential human carcinogen. Long-term exposure to levels above acceptable limits may increase the risk of cancer.

What You Should Do

  1. Check your prescription bottle for the product name 'Losartan Potassium Tablets USP' and the manufacturer 'Camber Pharmaceuticals, Inc.'
  2. Identify if your medication is affected by matching the strength (25 mg, 50 mg, or 100 mg), NDC numbers, and lot numbers. Affected 25 mg lots include LOP17026B, LOP17050, and LOP18057 with expirations between May 2019 and January 2020. Affected 50 mg lots include LOP17028C, LOP17064A, and LOP18096 with expirations between September 2019 and March 2020. Affected 100 mg lots include LOP17011, LOP18030, and LOP18133 with expirations between May 2019 and June 2020.
  3. Do NOT stop taking your medication immediately; abruptly stopping Losartan can lead to serious health risks from untreated high blood pressure.
  4. Contact your healthcare provider or pharmacist right away to discuss an alternative treatment or a replacement prescription before you stop taking the recalled medicine.
  5. Return any unused, recalled tablets to the pharmacy where you purchased them for a refund and further instructions.
  6. Contact Camber Pharmaceuticals Inc. or the manufacturer for additional questions regarding the return process.
  7. For general consumer safety questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Product return for refund and pharmacist consultation.

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
Model:
NDC 31722-700-90
NDC 31722-700-05
Lot Numbers:
LOP17026B (Exp. Sep-19)
LOP17050 (Exp. Sep-19)
LOP1705 (Exp. Sep-19)
LOP17052 (Exp. Sep-19)
LOP17053 (Exp. Sep-19)
LOP17061 (Exp. Oct-19)
LOP18035 (Exp. Dec-19)
LOP18036 (Exp. Dec-19)
LOP17026 (Exp. Sep-19)
LOP17006 (Exp. May-19)
LOP17025 (Exp. Sep-19)
LOP17068 (Exp. Oct-19)
LOP18037 (Exp. Dec-19)
LOP18038 (Exp. Dec-19)
LOP18039 (Exp. Dec-19)
LOP18057 (Exp. Jan-20)
Date Ranges: May-19, Sep-19, Oct-19, Dec-19, Jan-20
Product: Losartan Potassium Tablets USP, 50 mg
Model:
NDC 31722-701-30
NDC 31722-701-90
NDC 31722-701-10
Lot Numbers:
LOP17028C (Exp. Sep-19)
LOP17064A (Exp. Nov-19)
LOP17027 (Exp. Sep-19)
LOP17063 (Exp. Nov-19)
LOP17093 (Exp. Nov-19)
LOP17094 (Exp. Dec-19)
LOP17095 (Exp. Dec-19)
LOP17097A (Exp. Dec-19)
LOP17105 (Exp. Dec-19)
LOP17107 (Exp. Dec-19)
LOP17004 (Exp. Dec-19)
LOP17028B (Exp. Sep-19)
LOP17048 (Exp. Oct-19)
LOP17049 (Exp. Oct-19)
LOP17056 (Exp. Nov-19)
LOP17073 (Exp. Nov-19)
LOP17074 (Exp. Nov-19)
LOP17076 (Exp. Nov-19)
LOP17096 (Exp. Dec-19)
LOP18077A (Exp. Feb-20)
LOP18078 (Exp. Feb-20)
LOP18079 (Exp. Feb-20)
LOP18080 (Exp. Feb-20)
LOP18081 (Exp. Mar-20)
LOP18084 (Exp. Mar-20)
LOP18095 (Exp. Mar-20)
LOP18096 (Exp. Mar-20)
Date Ranges: Sep-19, Oct-19, Nov-19, Dec-19, Feb-20, Mar-20
Product: Losartan Potassium Tablets USP, 100 mg
Model:
NDC 31722-702-30
NDC 31722-702-10
Lot Numbers:
LOP17011 (Exp. Aug-19)
LOP17087 (Exp. Nov-19)
LOP17012 (Exp. Aug-19)
LOP17013 (Exp. Aug-19)
LOP17042 (Exp. Oct-19)
LOP17043 (Exp. Oct-19)
LOP17044 (Exp. Nov-19)
LOP17045 (Exp. Nov-19)
LOP18024 (Exp. Dec-19)
LOP18025 (Exp. Dec-19)
LOP18026 (Exp. Dec-19)
LOP18027 (Exp. Dec-19)
LOP18028 (Exp. Dec-19)
LOP18029 (Exp. Dec-19)
LOP18030 (Exp. Dec-19)
LOP17005 (Exp. May-19)
LOP17014 (Exp. Aug-19)
LOP17016 (Exp. Sep-19)
LOP17023 (Exp. Sep-19)
LOP17083 (Exp. Oct-19)
LOP17084 (Exp. Nov-19)
LOP17085 (Exp. Nov-19)
LOP17086 (Exp. Nov-19)
LOP18021 (Exp. Dec-19)
LOP18022 (Exp. Dec-19)
LOP18023 (Exp. Dec-19)
LOP18031 (Exp. Dec-19)
LOP18032 (Exp. Dec-19)
LOP18033 (Exp. Dec-19)
LOP18050 (Exp. Dec-19)
LOP18051 (Exp. Dec-19)
LOP18109 (Exp. Mar-20)
LOP18111 (Exp. Mar-20)
LOP18122 (Exp. Jun-20)
LOP18123 (Exp. Jun-20)
LOP18124 (Exp. Jun-20)
LOP18125 (Exp. Jun-20)
LOP18126 (Exp. Jun-20)
LOP18127 (Exp. Jun-20)
LOP18128 (Exp. Jun-20)
LOP18129 (Exp. Jun-20)
LOP18130 (Exp. Jun-20)
LOP18131C (Exp. Jun-20)
LOP18133 (Exp. Jun-20)
Date Ranges: May-19, Aug-19, Sep-19, Oct-19, Nov-19, Dec-19, Mar-20, Jun-20

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82281
Status: Active
Manufacturer: Camber Pharmaceuticals Inc
Sold By: Pharmacies
Manufactured In: United States, India
Units Affected: 3 products (351,732 bottles; 69712 bottles; 683,641 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.

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.