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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 Extraneous Material

Agency Publication Date: January 31, 2019
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Summary

Lupin Pharmaceuticals Inc. is recalling approximately 14,400 bottles of Cephalexin for Oral Suspension USP 250mg/5 mL, a prescription antibiotic used to treat bacterial infections. The recall was initiated because foreign material was found within the secondary packaging of the sucrose used as an ingredient in the medication. This defect occurred due to deviations from Good Manufacturing Practices (CGMP) during the production process.

Risk

The presence of extraneous material during the manufacturing process of an oral medication can lead to physical contamination of the drug, which may pose a risk of ingestion of foreign matter or impact the quality and safety of the final product.

What You Should Do

  1. Identify your product by checking the bottle for 'Cephalexin for Oral Suspension USP 250mg/5 mL' with NDC 68180-441-01.
  2. Check the packaging for lot number F801282 and an expiration date of June 2020.
  3. If you have this specific lot, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a safe replacement.
  4. Return any unused portion of the medication to the pharmacy where you purchased it for a refund and further instructions.
  5. Contact Lupin Pharmaceuticals at 1-888-723-3332 or visit their website for additional information regarding the return process.
  6. For further questions or to report an adverse event, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall baseline remedy

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/5 mL (14,400 bottles)
Model:
NDC 68180-441-01
Recall #: D-0423-2019
Lot Numbers:
F801282 (Expiry June 2020)
Date Ranges: June 2020 (Expiration)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81908
Status: Resolved
Manufacturer: Lupin Pharmaceuticals Inc.
Sold By: wholesalers; drug chains; supermarket
Manufactured In: India, United States
Units Affected: 14,400 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.