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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Breckenridge Pharmaceutical, Inc: Omeprazole Delayed-Release Capsules Recalled for Failed Impurity Specifications

Agency Publication Date: March 18, 2021
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Summary

Breckenridge Pharmaceutical, Inc. is recalling 3,146 bottles of Omeprazole Delayed-Release Capsules (20 mg, 1000 count bottles) because stability testing discovered unknown impurities that exceeded safety specifications. These prescription capsules are used to treat certain stomach and esophagus problems, such as acid reflux and ulcers. Consumers who have the affected medication should contact their doctor or pharmacist immediately as these impurities represent a failure to meet the drug's quality and degradation standards.

Risk

Testing revealed the presence of unknown chemical impurities or degradation products that exceeded approved safety limits. While the specific health impact of these impurities is unknown, taking medication that does not meet chemical specifications can result in reduced effectiveness or exposure to unintended substances.

What You Should Do

  1. Check your prescription bottle for Omeprazole Delayed-Release Capsules, USP, 20 mg in 1000 count bottles with NDC 51991-643-10.
  2. Verify if your bottle belongs to Lot # 191659 with an expiration date of 05/2021.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are currently taking medication from the affected lot.
  4. Return any unused portion of the affected medication to your pharmacy for a refund and to obtain a replacement from a safe lot.
  5. Contact Breckenridge Pharmaceutical, Inc. at their Berlin, CT location or through the contact information provided on your prescription label for further instructions.
  6. For additional questions or to report adverse events, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and refund

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

Affected Products

Product: Omeprazole Delayed-Release Capsules, USP, 20 mg (1000 count bottles)
Model:
NDC 51991-643-10
Recall #: D-0308-2021
Lot Numbers:
191659 (exp. date 05/2021)
Date Ranges: May 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87498
Status: Resolved
Manufacturer: Breckenridge Pharmaceutical, Inc
Sold By: pharmacies; healthcare providers
Manufactured In: Spain, United States
Units Affected: 3,146 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.