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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 Pharmaceuticals Inc.: Cephalexin for Oral Suspension Recalled for Manufacturing Record Issues

Agency Publication Date: January 16, 2019
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Summary

Lupin Pharmaceuticals Inc. has voluntarily recalled 7,215 bottles of Cephalexin for Oral Suspension USP, 250mg/5mL (200 mL when mixed). This prescription antibiotic was recalled because the company could not locate the required manufacturing batch records, which is a deviation from Current Good Manufacturing Practice (CGMP) standards. While no specific patient injuries or product defects have been reported, the lack of documentation means the quality and safety of these specific bottles cannot be fully verified. Consumers should contact their healthcare provider or pharmacist for guidance on how to handle their remaining medication.

Risk

The absence of manufacturing batch records means the producer cannot prove that this specific lot was made according to safety and quality standards. This creates a potential risk that unknown defects or contamination could exist, which might lead to ineffective treatment or unexpected side effects.

What You Should Do

  1. Check your prescription bottle for Cephalexin for Oral Suspension USP, 250mg/5mL, in the 200 mL size (when mixed).
  2. Verify the label for NDC 68180-0124-02 and look for lot number F602820 with an expiration date of December 2019.
  3. If you have this specific lot, contact your healthcare provider or pharmacist immediately to discuss continuing your treatment or obtaining a replacement prescription.
  4. Return any unused portion of the affected medication to your pharmacy for a refund.
  5. Contact Lupin Pharmaceuticals Inc. at their Baltimore, Maryland headquarters if you have further questions regarding this recall.
  6. For additional information, 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

Contact healthcare provider and return product for refund.

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

Affected Products

Product: Cephalexin for Oral Suspension USP, 250mg/5mL (200 mL when mixed)
Model:
NDC 68180-0124-02
Recall #: D-0380-2019
Lot Numbers:
F602820 (Expiry December 2019)
Date Ranges: Expiry December 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81898
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: 12 major distributors
Manufactured In: India, United States
Units Affected: 7,215 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.