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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Avet Pharmaceuticals, Inc.: Losartan Potassium Tablets Recalled Due to Excessive Impurity Levels

Agency Publication Date: April 7, 2020
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Summary

Avet Pharmaceuticals, Inc. is recalling 15,072 units of Losartan Potassium Tablets USP (50 mg and 100 mg), a prescription medication used to treat high blood pressure. Testing by the FDA confirmed that the tablets contain an impurity called N-Methylnitrosobutyric acid (NMBA) at levels higher than the acceptable daily intake limit. Consumers should contact their healthcare provider or pharmacist immediately for advice on alternative treatments before they stop taking this medication, as the risks of suddenly stopping blood pressure medicine may outweigh the risks of the impurity.

Risk

The tablets contain NMBA, which is a known environmental contaminant and a potential human carcinogen. Long-term exposure to this impurity above acceptable safety levels may increase the risk of cancer.

What You Should Do

  1. Check your prescription bottle for Losartan Potassium Tablets USP 50 mg with NDC 23155-645-03 (30 count), NDC 23155-645-09 (90 count), or NDC 23155-645-10 (1000 count). Specifically look for lot numbers CL018008A (Exp Mar 2020), CL018008B (Exp Mar 2020), or CL018009A (Exp Mar 2020).
  2. Check your prescription bottle for Losartan Potassium Tablets USP 100 mg with NDC 23155-646-03 (30 count), NDC 23155-646-09 (90 count), or NDC 23155-646-10 (1000 count). Specifically look for lots CL018022B, CL018010A, CL018017B, CL018018A, CL018011A, CL018012A, CL018013A, CL018015A, CL018016A, or CL018017A with expiration dates in March or April 2020.
  3. If you identify your medication as part of this recall, contact your healthcare provider or pharmacist immediately to discuss a replacement or alternative treatment plan.
  4. Do not stop taking the medication until you have spoken with a medical professional, as stopping blood pressure medication abruptly can pose significant health risks.
  5. Return any unused product to your pharmacy for a refund and contact Avet Pharmaceuticals at the distributor address (1 Tower Center Blvd Ste 1700, East Brunswick, NJ) for further information.
  6. For additional 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

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a 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 50 mg (30 count)
Model:
NDC 23155-645-03
Lot Numbers:
CL018008A (Exp Mar 2020)
Date Ranges: March 2020
Product: Losartan Potassium Tablets USP 50 mg (90 count)
Model:
NDC 23155-645-09
Lot Numbers:
CL018008B (Exp Mar 2020)
Date Ranges: March 2020
Product: Losartan Potassium Tablets USP 50 mg (1000 count)
Model:
NDC 23155-645-10
Lot Numbers:
CL018009A (Exp Mar 2020)
Date Ranges: March 2020
Product: Losartan Potassium Tablets USP 100 mg (30 count)
Model:
NDC 23155-646-03
Lot Numbers:
CL018022B (Exp Apr 2020)
Date Ranges: April 2020
Product: Losartan Potassium Tablets USP 100 mg (90 count)
Model:
NDC 23155-646-09
Lot Numbers:
CL018010A (Exp Mar 2020)
CL018017B (Exp Apr 2020)
CL018018A (Exp Apr 2020)
Date Ranges: March 2020, April 2020
Product: Losartan Potassium Tablets USP 100 mg (1000 count)
Model:
NDC 23155-646-10
Lot Numbers:
CL018011A (Exp Mar 2020)
CL018012A (Exp Mar 2020)
CL018013A (Exp Apr 2020)
CL018015A (Exp Apr 2020)
CL018016A (Exp Apr 2020)
CL018017A (Exp Apr 2020)
Date Ranges: March 2020, April 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85283
Status: Resolved
Manufacturer: Avet Pharmaceuticals, Inc.
Sold By: Pharmacies
Manufactured In: India
Units Affected: 2 products (a) 2,904; b) 14,316; c) 1,368 bottles; a) 12,168; b) 17,196; c) 3,890)
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.