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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

Boehringer Ingelheim Pharmaceuticals, Inc.: Catapres (Clonidine Hydrochloride) Recalled for Dissolution Testing Failure

Agency Publication Date: October 23, 2020
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Summary

Boehringer Ingelheim Pharmaceuticals is recalling 13,270 bottles of Catapres (clonidine hydrochloride) tablets in 0.1 mg, 0.2 mg, and 0.3 mg strengths. The recall was initiated because testing showed an 'extraneous peak' during dissolution tests, meaning the medication may not break down or be absorbed by the body as intended. These prescription tablets were distributed nationwide in the USA and Puerto Rico in 100-count bottles.

Risk

An extraneous peak during dissolution testing indicates a potential impurity or a change in how the drug dissolves, which could affect the medication's effectiveness or safety profile. While no specific injuries have been reported, inconsistent dissolution can lead to unpredictable blood pressure control.

What You Should Do

  1. Identify your medication by checking the bottle for the name Catapres (clonidine hydrochloride, USP) and the strength (0.1 mg, 0.2 mg, or 0.3 mg).
  2. For 0.1 mg tablets, check for Lot # 761544, 859015 (Exp Jan 2021), 861346, or 956626 (Exp Jan 2022) with NDC 0597-0006-01.
  3. For 0.2 mg tablets, check for Lot # 861135 or C34139 with expiration date Nov 2021 and NDC 0597-0007-01.
  4. For 0.3 mg tablets, check for Lot # 954953 with expiration date Jan 2022 and NDC 0597-0011-01.
  5. Contact your healthcare provider or pharmacist immediately for guidance if you find your medication is part of this recall; do not stop taking prescribed blood pressure medication without consulting a professional.
  6. Return any unused tablets from the affected lots to your pharmacy for a refund and contact Boehringer Ingelheim Pharmaceuticals at 1-800-542-6257 for further instructions.
  7. Contact the FDA Consumer Complaint coordinator at 1-888-723-3332 for additional questions regarding drug safety.

Your Remedy Options

💰Full Refund

Consultation and refund via pharmacy.

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

Affected Products

Product: Catapres (clonidine hydrochloride, USP) 0.1 mg (100-count bottle)
Model:
NDC 0597-0006-01
Lot Numbers:
761544
859015 (Exp Jan 2021)
861346
956626 (Exp Jan 2022)
Date Ranges: January 2021, January 2022
Product: Catapres (clonidine hydrochloride, USP) 0.2 mg (100-count bottle)
Model:
NDC 0597-0007-01
Lot Numbers:
861135
C34139 (Exp Nov 2021)
Date Ranges: November 2021
Product: Catapres (clonidine hydrochloride, USP) 0.3 mg (100-count bottle)
Model:
NDC 0597-0011-01
Lot Numbers:
954953 (Exp Jan 2022)
Date Ranges: January 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86527
Status: Resolved
Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.
Sold By: Pharmacies
Manufactured In: Germany, United States
Units Affected: 13,270 bottles/100 tablets each
Distributed To: Nationwide
Agency Last Updated: October 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.