Medications & Supplements/Prescription Drugs

Lupin Pharmaceuticals Inc.: Cefixime Oral Suspension Recalled for Being Subpotent

Agency Publication Date: May 19, 2021

Summary

Lupin Pharmaceuticals Inc. has recalled 3,138 bottles of Cefixime for Oral Suspension USP (100 mg/5mL) because the medication was found to be subpotent. This prescription antibiotic, used to treat various bacterial infections, may not contain the full strength of the active ingredient required for effective treatment. Consumers who have this medication should contact their healthcare provider or pharmacist, as an under-strength antibiotic can lead to treatment failure or the development of antibiotic-resistant bacteria.

Risk

The medication is subpotent, meaning it does not contain the required amount of the active drug to properly treat an infection. This poses a risk of the underlying bacterial infection not being cured or worsening, and may contribute to the development of drug-resistant bacteria.

What You Should Do

Locate your bottle of Cefixime for Oral Suspension USP 100 mg/5mL (50mL HDPE bottle) and check the label for NDC 68180-405-01.
Check the packaging for Lot Number F900787 and an expiration date of 4/2021 to see if your medication is part of the recall.
If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options and to ensure your infection is being properly treated.
Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund.
Contact Lupin Pharmaceuticals Inc. for further instructions regarding this recall at their Baltimore, Maryland headquarters.
For additional questions or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and refund

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 100 mg/5mL (50mL bottle)

Model:

NDC 68180-405-01

Recall #: D-0390-2021

Lot Numbers:

F900787 (Exp. Date 4/2021)

Date Ranges: April 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87871

Status: Resolved

Manufacturer: Lupin Pharmaceuticals Inc.

Sold By: Pharmacies

Manufactured In: United States, India

Units Affected: 3,138 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 100 mg/5mL (50mL HDPE bottle) and check the label for NDC 68180-405-01.

Check the packaging for Lot Number F900787 and an expiration date of 4/2021 to see if your medication is part of the recall.

If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately to discuss alternative treatment options and to ensure your infection is being properly treated.

Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund.

Contact Lupin Pharmaceuticals Inc. for further instructions regarding this recall at their Baltimore, Maryland headquarters.

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