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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

Cefixime Capsules 400 mg Recalled for Impurity and Degradation Issues

Agency Publication Date: November 9, 2021
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Summary

Ascend Laboratories LLC has voluntarily recalled approximately 4,104 bottles of Cefixime Capsules 400 mg (cefixime), an antibiotic used to treat various bacterial infections. The medication is being recalled because it failed specifications for impurities and degradation during testing. This means the drug may be less effective or may contain unintended substances that could lead to adverse health effects. No incidents or injuries have been reported to date.

Risk

Degraded medication may not provide the full dose of antibiotic needed to treat an infection, potentially leading to treatment failure. Impurities may also cause unexpected side effects or allergic reactions.

What You Should Do

  1. This recall affects Ascend Laboratories LLC Cefixime Capsules 400 mg sold in 50-count bottles under NDC 67877-584-50.
  2. Check your medication bottle for lot number 20140282 with an expiration date of December 2021.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Ascend Laboratories LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cefixime Capsules 400 mg (50 capsules bottle)
Variants: 400 mg, Capsules
Lot Numbers:
20140282 (Exp Dec 2021)
NDC:
67877-584-50

Manufactured by Alken Laboratories Ltd., India; Recall #: D-0229-2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88982
Status: Resolved
Manufacturer: Ascend Laboratories LLC
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 4104 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.