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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Bisoprolol Fumarate and HCTZ Tablets Recalled for Ezetimibe Contamination

Agency Publication Date: December 1, 2025
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Summary

Glenmark Pharmaceuticals Inc., USA is voluntarily recalling 11,136 bottles of Bisoprolol Fumarate and Hydrochlorothiazide Tablets (2.5 mg/6.25 mg), a medication used to treat high blood pressure. Testing discovered that reserve samples of the medication contained traces of ezetimibe, a different drug used to treat high cholesterol. This cross-contamination occurred during the manufacturing process. Consumers who have these tablets should contact their healthcare provider or pharmacist regarding their treatment.

Risk

The presence of traces of ezetimibe in a blood pressure medication represents a cross-contamination risk, which could lead to unexpected side effects or drug interactions for patients unaware they are consuming an additional active pharmaceutical ingredient.

What You Should Do

  1. Check your medication bottles for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg with NDC codes 68462-878-30 (30-count), 68462-878-01 (100-count), or 68462-878-05 (500-count).
  2. Look for lot numbers 17232401 (expiration 11/2025) or 17240974 (expiration 05/2026) printed on the bottle label.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP (30, 100, or 500-count bottles)
Variants: 2.5 mg/6.25 mg
Lot Numbers:
17232401 (Exp 11/2025)
17240974 (Exp 05/2026)
NDC:
68462-878-30
68462-878-01
68462-878-05

Manufactured by Glenmark Pharmaceuticals Limited, Pithampur, India for Glenmark Pharmaceuticals, Inc., USA.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98036
Status: Active
Manufacturer: Glenmark Pharmaceuticals Inc., USA
Sold By: Retail Pharmacies
Manufactured In: India
Units Affected: 11,136 bottles
Distributed To: Nationwide

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.