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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

Mylan Pharmaceuticals Inc.: Amlodipine and Benazapril HCL Capsules Recalled for Manufacturing Deviations

Agency Publication Date: May 17, 2018
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Summary

Mylan Pharmaceuticals is recalling 38,412 bottles of Amlodipine and Benazapril HCL Capsules, a medication used to treat high blood pressure. Approximately 25,488 bottles of the 5 mg/10 mg strength and 12,924 bottles of the 5 mg/40 mg strength are affected. The recall was initiated because the cleaning procedures for the equipment used to manufacture these specific batches were not properly followed, which could lead to cross-contamination between different drug products.

Risk

Failure to follow proper equipment cleaning procedures creates a risk that residue from previously manufactured drugs could contaminate these capsules. This cross-contamination may cause patients to be exposed to unintended medications, potentially leading to adverse reactions or reduced effectiveness of their blood pressure treatment.

What You Should Do

  1. Check your prescription bottle to see if you have Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg (100 count bottles) with NDC 0378-6896-01 and Lot Numbers 3083005, 3083006, 3086121, or 3086122 with an expiration date of Jan 2019.
  2. Check your prescription bottle to see if you have Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg (100 count bottles) with NDC 0378-6899-01 and Lot Numbers 3083008 or 3086124 with an expiration date of Jan 2019.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you identify that your medication is part of this recall. Do not stop taking your blood pressure medication without consulting a professional first.
  4. Return any unused product from the affected lots to your pharmacy to receive a refund.
  5. Contact Mylan Pharmaceuticals Inc. at their headquarters in Morgantown, West Virginia, or through your dispensing pharmacy for further instructions regarding the return process.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

💰Full Refund

Contact healthcare provider and return to pharmacy.

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

Affected Products

Product: Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg (100 count bottles)
Model:
NDC 0378-6896-01
Lot Numbers:
3083005 (Exp Jan 2019)
3083006 (Exp Jan 2019)
3086121 (Exp Jan 2019)
3086122 (Exp Jan 2019)
Date Ranges: Expiration Jan 2019
Product: Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg (100 count bottles)
Model:
NDC 0378-6899-01
Lot Numbers:
3083008 (Exp Jan 2019)
3086124 (Exp Jan 2019)
Date Ranges: Expiration Jan 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79957
Status: Resolved
Manufacturer: Mylan Pharmaceuticals Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (25,488 bottles; 12,924 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 · 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.