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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 Pharmaceuticals Inc.: Lisinopril and Hydrochlorothiazide Tablets Recalled for Foreign Substance

Agency Publication Date: August 9, 2019
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Summary

Lupin Pharmaceuticals Inc. has recalled 39,216 bottles of Lisinopril and Hydrochlorothiazide (10 mg/12.5 mg) tablets, a prescription medication used to treat high blood pressure. This recall was initiated after reports of brownish or blackish stains on the tablets themselves and a similar dark powder found inside the bottles. Consumers are advised to check their medication bottles for specific batch number H900575 and contact their healthcare provider immediately for guidance.

Risk

The presence of an unknown foreign substance, identified as brownish or blackish stains and powder, poses a risk of contamination which could lead to adverse health effects or reduced drug effectiveness. While no specific injuries have been reported, the contamination indicates a quality failure that may compromise patient safety.

What You Should Do

  1. Check your prescription bottle for Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg with NDC 68180-518-01.
  2. Identify if your bottle belongs to Batch H900575 with an expiration date of 01/2022.
  3. Inspect the tablets and the inside of the bottle for any unusual brownish or blackish stains or powder.
  4. Contact your healthcare provider or pharmacist immediately for guidance if you possess the recalled medication, and do not stop taking your blood pressure medication without consulting a professional.
  5. Return any unused product to the pharmacy where it was purchased for a refund and contact Lupin Pharmaceuticals Inc. at 1-866-587-4617 for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

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: Consumers should contact their doctor or pharmacist regarding the recall and return the affected product to the point of purchase for a refund.

Affected Products

Product: Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg (100 tablet bottle)
Model:
NDC 68180-518-01
Recall #: D-1720-2019
Lot Numbers:
H900575 (Exp 01/2022)
Date Ranges: Expiration date 01/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83354
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: wholesalers; distributors; supermarket chains; drug chains
Manufactured In: United States, India
Units Affected: 39,216 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.