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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

Lupin Cefdinir for Oral Suspension Recalled for Lack of Seal Integrity

Agency Publication Date: May 29, 2024
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Summary

Lupin Pharmaceuticals Inc. has voluntarily recalled 51,006 bottles of Cefdinir for Oral Suspension USP (250 mg/5 mL), an antibiotic used to treat various bacterial infections. This recall was issued because the bottles were found to have defective containers that lack proper seal integrity. If you have health concerns about this medication, contact your healthcare provider or pharmacist for guidance. You should return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Risk

A lack of seal integrity can expose the medication to air or moisture, which may compromise the drug's stability and make it less effective at treating infections. There are no reports of injuries to date.

What You Should Do

  1. The recalled product is Cefdinir for Oral Suspension USP (250 mg/5 mL) packaged in 60 mL bottles with NDC 68180-723-04.
  2. Identify affected bottles by looking for lot numbers F305184, F305185, or F305186, all with an expiration date of 7/31/2025.
  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 the manufacturer 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: Cefdinir for Oral Suspension USP (60 mL bottle)
Variants: 250 mg/5 mL, Rx only
Lot Numbers:
F305184 (Exp 7/31/2025)
F305185 (Exp 7/31/2025)
F305186 (Exp 7/31/2025)
NDC:
68180-723-04

Quantity affected: 51,006 bottles.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94602
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: Pharmacies; Hospitals
Manufactured In: United States, India
Units Affected: 51,006 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.