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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

Unichem Pharmaceuticals Usa Inc: Bisoprolol Fumarate Tablets Recalled for Failed Impurity Specifications

Agency Publication Date: October 18, 2017
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Summary

Unichem Pharmaceuticals is recalling approximately 96,876 bottles of Bisoprolol Fumarate tablets (5 mg, 30-count bottles). This prescription medication, which is used to treat high blood pressure, was found to contain an unknown impurity that was discovered during 18-month stability testing. The product was distributed nationwide to pharmacies and distributors between 2016 and 2018. If you have this medication, you should consult your pharmacist or doctor before stopping use, as stopping blood pressure medication abruptly can be dangerous.

Risk

The presence of unknown impurities or degradation products means the medication no longer meets safety and quality standards, which could potentially cause unexpected side effects or reduce the drug's effectiveness over time.

What You Should Do

  1. Check your medication bottle to see if it is Bisoprolol Fumarate tablets, 5 mg, in 30-count bottles with NDC 29300-126-13.
  2. Verify if your bottle matches lot numbers GBOL16001 (Exp 12/31/2017), GBOL16002 (Exp 12/31/2017), or GBOL16015 (Exp 03/31/2018).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if your medication is part of the recall.
  4. Return any unused product to the pharmacy where it was purchased for a refund and contact Unichem Pharmaceuticals USA Inc. for further instructions.
  5. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

๐Ÿ’ฐFull Refund
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Bisoprolol Fumarate tablets, 5 mg, 30-count bottles
Model:
NDC 29300-126-13
Recall #: D-0010-2018
Lot Numbers:
GBOL16001 (Exp 12/31/2017)
GBOL16002 (Exp 12/31/2017)
GBOL16015 (Exp 03/31/2018)
Date Ranges: Expiration date 12/31/2017, Expiration date 03/31/2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78218
Status: Resolved
Manufacturer: Unichem Pharmaceuticals Usa Inc
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 96,876 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.