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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 Oral Suspension Recalled for Failed Impurity Specifications

Agency Publication Date: January 26, 2024
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Summary

Lupin Pharmaceuticals Inc. is recalling 4,608 bottles of Cefixime for Oral Suspension (100mg/5mL). This prescription antibiotic is used to treat various bacterial infections. The recall was initiated because the product failed to meet quality specifications for impurities or degradation, which could affect the medication's effectiveness or safety. No injuries or illnesses have been reported to date.

Risk

Using medication that has degraded or contains unexpected impurities can mean the treatment is less effective or contains substances that should not be there. This could result in a bacterial infection failing to clear as expected or causing unforeseen side effects.

What You Should Do

  1. This recall affects Cefixime for Oral Suspension 100mg/5mL, sold in 50 mL bottles under the NDC 68180-405-01. The affected product is Lot F304833 with an expiration date of June 2025 (06/2025).
  2. 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 Lupin Pharmaceuticals Inc. for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

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 for Oral Suspension (50 mL)
Variants: 100mg/5mL, Rx Only
Lot Numbers:
F304833 (Exp 06/2025)
NDC:
68180-405-01

Manufactured for Lupin Pharmaceuticals, Inc. by Lupin Limited in India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93730
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Nationwide distributors
Manufactured In: India, United States
Units Affected: 4,608 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.