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Drug recall · FDA · Published June 28, 2018

LUPIN SOMERSET recalls Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc.

Lupin Somerset recalls 230mL Nitrofurantoin Oral Suspension due to subpotent drug and failed content uniformity. This may not provide effective treatment for urinary tract infections. Consumers should contact the manufacturer for details.

🇺🇸 FDA recall #D-0927-2018DrugLupin Somerset ›
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Contact the company & request your remedy

Recalling firmLUPIN SOMERSET400 Campus Dr · Somerset, NJ 08873-1145
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Lupin Somerset is recalling 230mL bottles of Nitrofurantoin Oral Suspension (25mg/5mL) because the medication may not be strong enough to treat urinary tract infections. This could lead to ineffective treatment if used without proper dosage. Read more at govinfonow.com/recall/40392-lupin-somerset-nitrofurantoin-oral-suspension-recall-subpotent-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/40392-lupin-somerset-nitrofurantoin-oral-suspension-recall-subpotent-drug-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0927-2018

Cite this page

“Lupin Somerset Nitrofurantoin Oral Suspension Recall: Subpotent Drug Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40392-lupin-somerset-nitrofurantoin-oral-suspension-recall-subpotent-drug-risk. Based on FDA recall #D-0927-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0927-2018%22&limit=1).

Why it’s dangerous

The medication may not contain enough active ingredient to effectively treat urinary tract infections. This could result in the infection not being properly treated if the medication is used as directed.

Who’s affected

People who have a prescription for this medication from a doctor. Those with urinary tract infections who need treatment are most at risk.

How to tell if you have this one

Check for the 230mL bottle labeled Nitrofurantoin Oral Suspension USP, 25mg/5mL, Rx Only. The product was manufactured by Novel Laboratories, Inc. and distributed by Lupin Pharmaceuticals, Inc.

  • Brand
    Lupin Somerset
  • Product
    Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc.
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Contact Manufacturer

    Reach out to Lupin Pharmaceuticals, Inc. for specific instructions on handling the recalled product.

✎ GovInfoNow

Questions people ask

Is this medication safe to use?

The recall indicates the medication may not be strong enough to treat urinary tract infections, so it is not recommended for use.

How can I tell if I have the recalled product?

Check for the 230mL bottle labeled Nitrofurantoin Oral Suspension USP, 25mg/5mL, Rx Only with the specific lot numbers and expiration dates mentioned in the recall.

What should I do if I have this medication?

Contact Lupin Pharmaceuticals, Inc. for specific instructions on handling the recalled product.

Take action

Contact Lupin Somerset

We’ve drafted a message you can send Lupin Somerset to request your refund or repair — edit it as you like.

Subject: Recall D-0927-2018 — Lupin Somerset Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured b

Hello,

I own a Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. that is covered by recall D-0927-2018 from Lupin Somerset.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0927-2018 (June 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0927-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA