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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

Hetero Labs Limited (Unit V): Losartan Potassium Tablets USP Recalled for Failed Tablet Specifications

Agency Publication Date: August 21, 2020
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Summary

Approximately 43,512 bottles of Losartan Potassium (50 mg), a prescription medication used to treat high blood pressure, have been recalled by Hetero Labs Limited. The recall was initiated following a consumer complaint about a 'bulging' tablet, which indicates the product failed to meet physical quality and appearance specifications. These affected 90-count bottles were manufactured for Camber Pharmaceuticals and distributed to major wholesalers and distributors across the United States. While no specific injuries have been reported, consumers should check their medication bottles immediately for the affected batch number.

Risk

The tablets failed to meet the required physical specifications, as evidenced by a report of a bulging tablet. This defect may affect the consistency, dosage, or stability of the medication, potentially impacting its effectiveness in managing blood pressure.

What You Should Do

  1. Check your prescription bottle label to see if you have Losartan Potassium Tablets USP, 50 mg, in 90-count bottles manufactured for Camber Pharmaceuticals.
  2. Verify if your medication is part of the recall by looking for Batch # LOA19357A with an expiration date of 09/2021.
  3. If you identify your medication as part of the recalled batch, contact your healthcare provider or pharmacist immediately to discuss an alternative treatment or replacement; do not stop taking your medication without consulting a medical professional.
  4. Contact Hetero Labs Limited or Camber Pharmaceuticals to arrange for the return of any unused product for a refund.
  5. For further questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance.

How to: Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: Losartan Potassium Tablets USP, 50 mg (90 count bottles)
Model:
Recall #: D-1545-2020
Lot Numbers:
LOA19357A (Exp 09/2021)
Date Ranges: 09/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86191
Status: Resolved
Manufacturer: Hetero Labs Limited (Unit V)
Sold By: wholesalers; distributors
Manufactured In: India
Units Affected: 43,512 bottles
Distributed To: Nationwide
Agency Last Updated: August 26, 2020

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 · 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.