Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Cefixime Oral Suspension Recalled for Subpotency

Agency Publication Date: April 23, 2020

Summary

Lupin Pharmaceuticals Inc. is recalling 4,518 bottles of Cefixime for Oral Suspension USP (100mg/5mL) because the medication was found to be subpotent. Testing during a long-term stability study showed that the active ingredient level fell below required specifications, meaning the drug may not be strong enough to treat infections effectively. This prescription antibiotic was distributed nationwide across the United States and Puerto Rico in 50mL bottles.

Risk

Because the drug is subpotent, patients may receive a lower dose of the antibiotic than intended, which could lead to treatment failure or the worsening of the infection being treated. No specific injuries or adverse events have been reported to date.

What You Should Do

Locate your bottle of Cefixime for Oral Suspension USP, 100mg/5mL and check the label for NDC 68180-405-01.
Identify if your medication is part of the recall by looking for Lot Number F800779 with an Expiration Date of 4/2020.
Contact your healthcare provider or pharmacist immediately if you are currently taking this medication to discuss alternative treatment options and to ensure your infection is being properly managed.
Return any remaining unused product from this specific lot to your pharmacy to receive a refund and to ensure the subpotent medication is properly handled.
Contact Lupin Pharmaceuticals Inc. at their Baltimore office or via the contact methods provided by your pharmacist for further instructions regarding the return process.
For additional questions or to report side effects, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full 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: Cefixime for Oral Suspension USP, 100mg/5mL

Model:

NDC 68180-405-01

Recall #: D-1252-2020

Lot Numbers:

F800779 (Expiry 4/2020)

Date Ranges: Expiry 4/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85487

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: India, United States

Units Affected: 4,518 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 · 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.

Summary

What You Should Do

Locate your bottle of Cefixime for Oral Suspension USP, 100mg/5mL and check the label for NDC 68180-405-01.

Identify if your medication is part of the recall by looking for Lot Number F800779 with an Expiration Date of 4/2020.

Contact your healthcare provider or pharmacist immediately if you are currently taking this medication to discuss alternative treatment options and to ensure your infection is being properly managed.

Return any remaining unused product from this specific lot to your pharmacy to receive a refund and to ensure the subpotent medication is properly handled.

Contact Lupin Pharmaceuticals Inc. at their Baltimore office or via the contact methods provided by your pharmacist for further instructions regarding the return process.

For additional questions or to report side effects, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.