Medications & Supplements/Prescription Drugs

LUPIN SOMERSET: Nitrofurantoin Oral Suspension Recalled for Subpotency and Dosage Issues

Agency Publication Date: July 12, 2018

Summary

Approximately 3,456 cartons of Nitrofurantoin Oral Suspension USP (25mg/5mL) are being recalled because the medication may be subpotent and has failed content uniformity tests. This means the drug may not contain the correct amount of active ingredient in every dose, which could lead to ineffective treatment of infections. Consumers who have this prescription antibiotic should check their 230 mL bottles for the specific lot numbers S700065 or 700619. You should contact your doctor or pharmacist immediately to discuss an alternative treatment or replacement medication.

Risk

The drug failed to meet potency and uniformity standards, meaning a patient may receive less than the intended dose of the antibiotic. This can result in the failure to treat an underlying bacterial infection, potentially allowing the infection to worsen or become more difficult to treat.

What You Should Do

Check your prescription bottle of Nitrofurantoin Oral Suspension USP (25mg/5mL, 230 mL) for Lot number S700065 with expiration date 02/2019, or Lot number 700619 with expiration date 08/2019.
Verify the UPC code 343386-450-114 and NDC 43386-450-11 located on the product packaging to confirm it is part of this recall.
If you identify your medication as part of the recall, contact your healthcare provider or pharmacist immediately to obtain a replacement or alternative treatment and for guidance on how to manage your current dosage.
Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund and to ensure the product is properly disposed of.
Contact Lupin Pharmaceuticals at their Somerset, New Jersey location if you have additional questions regarding the return process.
For further information or to report any adverse reactions, 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

Healthcare consultation and pharmacy refund.

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

Affected Products

Product: Nitrofurantoin Oral Suspension USP, 25mg/5mL (230 mL Bottle)

Model:

NDC 43386-450-11

Recall #: D-0927-2018

UPC Codes:

343386450114

Lot Numbers:

S700065 (Exp. 02/2019)

700619 (Exp. 08/2019)

Date Ranges: Exp. 02/2019, Exp. 08/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80377

Status: Resolved

Manufacturer: LUPIN SOMERSET

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 3456 cartons

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

Check your prescription bottle of Nitrofurantoin Oral Suspension USP (25mg/5mL, 230 mL) for Lot number S700065 with expiration date 02/2019, or Lot number 700619 with expiration date 08/2019.

Verify the UPC code 343386-450-114 and NDC 43386-450-11 located on the product packaging to confirm it is part of this recall.

If you identify your medication as part of the recall, contact your healthcare provider or pharmacist immediately to obtain a replacement or alternative treatment and for guidance on how to manage your current dosage.

Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund and to ensure the product is properly disposed of.

Contact Lupin Pharmaceuticals at their Somerset, New Jersey location if you have additional questions regarding the return process.

For further information or to report any adverse reactions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.