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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

UNICHEM PHARMACEUTICALS USA INC: Clonidine Hydrochloride Tablets Recalled for Impurity Migration Risk

Agency Publication Date: February 5, 2020
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Summary

Unichem Pharmaceuticals USA Inc. is recalling approximately 19,161,600 units of Clonidine Hydrochloride Tablets USP 0.1mg, a prescription medication used to treat high blood pressure. The recall was issued as a precaution because a chemical called Benzophenone may have migrated from the container label into the tablets at very low levels. This issue was discovered when the product failed testing for impurities and degradation specifications. Consumers should contact their doctor or pharmacist for advice on continued treatment.

Risk

Benzophenone, a chemical used in some label inks, may have moved from the bottle's label into the medicine itself. While the levels are reported to be very low, the presence of this unintended impurity means the tablets do not meet required quality and safety standards.

What You Should Do

  1. Identify your medication by checking the bottle for 'Clonidine Hydrochloride Tablets, USP 0.1mg' with NDC 29300-135-01.
  2. Check the bottle label for the following lot numbers and expiration dates: GCLL18108 (Exp 10/31/2020), GCLL18109 (Exp 10/31/2020), GCLL18110 (Exp 10/31/2020), or GCLL19003 (Exp 12/31/2020).
  3. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription before you stop taking this medication.
  4. Return any remaining tablets from the affected lots to your pharmacy for a refund.
  5. Contact Unichem Pharmaceuticals USA Inc. at their East Brunswick, NJ office for further information regarding this voluntary recall.
  6. For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Clonidine Hydrochloride Tablets, USP 0.1mg (100-count bottle)
Model:
NDC 29300-135-01
Recall #: D-0829-2020
Lot Numbers:
GCLL18108 (Exp 10/31/2020)
GCLL18109 (Exp 10/31/2020)
GCLL18110 (Exp 10/31/2020)
GCLL19003 (Exp 12/31/2020)
Date Ranges: Expiration 10/31/2020, Expiration 12/31/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84836
Status: Resolved
Manufacturer: UNICHEM PHARMACEUTICALS USA INC
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 19161600 units
Distributed To: Nationwide
Agency Last Updated: February 6, 2020

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.