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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 SOMERSET: Nitrofurantoin Oral Suspension Recalled for Being Subpotent

Agency Publication Date: December 31, 2018
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Summary

Lupin Somerset is recalling approximately 23,460 bottles of Nitrofurantoin Oral Suspension, USP (25mg/5mL), an antibiotic used to treat urinary tract infections. This recall is an expansion of a previous action because testing showed the medication is subpotent, meaning it contains less of the active ingredient than required. This generic medication was distributed nationwide in the United States and Puerto Rico in 230 mL bottles.

Risk

Because the medication is subpotent, it may not effectively treat the infection it was prescribed for. This could lead to a lack of improvement in symptoms or a worsening of the underlying infection.

What You Should Do

  1. Locate your Nitrofurantoin Oral Suspension, USP (25mg/5mL) 230 mL bottle and check the NDC number 43386-450-11 on the label.
  2. Check the bottle for the following affected lot numbers and expiration dates: S700038, S700044, S700059, or S700065 (Exp 28-Feb-19); S700410 or S700427 (Exp 30-Jun-19); S700617 or S700619 (Exp 31-Aug-19); S700813, S700815, or S700869 (Exp 31-Oct-19); S700871 or S700873 (Exp 30-Nov-19); or S700875 or S701073 (Exp 31-Dec-19).
  3. Contact your healthcare provider or pharmacist immediately for guidance if you are currently using medication from an affected lot.
  4. Return any unused product from the listed lots to your pharmacy to receive a refund.
  5. Contact the manufacturer, Lupin Somerset (also known as Novel Laboratories, Inc.), for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Return to pharmacy 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: Nitrofurantoin Oral Suspension, USP, 25mg/5mL (230 mL bottle)
Model:
NDC 43386-450-11
Recall #: D-0346-2019
Lot Numbers:
S700038 (Exp 28-Feb-19)
S700044 (Exp 28-Feb-19)
S700059 (Exp 28-Feb-19)
S700065 (Exp 28-Feb-19)
S700410 (Exp 30-Jun-19)
S700427 (Exp 30-Jun-19)
S700617 (Exp 31-Aug-19)
S700619 (Exp 31-Aug-19)
S700813 (Exp 31-Oct-19)
S700815 (Exp 31-Oct-19)
S700869 (Exp 31-Oct-19)
S700871 (Exp 30-Nov-19)
S700873 (Exp 30-Nov-19)
S700875 (Exp 31-Dec-19)
S701073 (Exp 31-Dec-19)
Date Ranges: Exp 28-Feb-19, Exp 30-Jun-19, Exp 31-Aug-19, Exp 31-Oct-19, Exp 30-Nov-19, Exp 31-Dec-19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81865
Status: Resolved
Manufacturer: LUPIN SOMERSET
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 23,460 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.