LUPIN SOMERSET recalls Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc.,
Lupin Somerset recalls specific lots of Nitrofurantoin Oral Suspension due to subpotent drug levels. This may not provide effective treatment for urinary tract infections. Consumers should check lot numbers and contact the manufacturer for details.
Lower-risk recall
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Contact the company & request your remedy
What happened, in plain English
Lupin Somerset is recalling certain lots of Nitrofurantoin Oral Suspension because the drug may be less potent than specified. This could lead to ineffective treatment for urinary tract infections if used without proper dosing. Read more at govinfonow.com/recall/39295-lupin-somerset-nitrofurantoin-oral-suspension-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39295-lupin-somerset-nitrofurantoin-oral-suspension-recall-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0346-2019
Cite this page
“Lupin Somerset Nitrofurantoin Oral Suspension Recall: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39295-lupin-somerset-nitrofurantoin-oral-suspension-recall-subpotent-drug-risk. Based on FDA recall #D-0346-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0346-2019%22&limit=1).
Why it’s dangerous
The medication may contain less active drug than specified, leading to reduced effectiveness in treating urinary tract infections. This could result in the infection not being properly treated if the product is used as directed.
Who’s affected
People who have been prescribed Nitrofurantoin Oral Suspension from Lupin Somerset with the specific lot numbers listed in the recall. Those with urinary tract infections are most at risk of ineffective treatment.
How to tell if you have this one
Check the product label for the lot numbers: S700038, S700044, S700059, S700065 (expiring February 2019), S700410, S700427 (expiring June 2019), S700617, S700619 (expiring August 2019), S700813, S700815, S700869 (expiring October 2019), S700871, S700873 (expiring November 2019), S700875, S701073 (expiring December 2019).
- Brand
Lupin Somerset- Category
Drug
What to do — step by step
Check Product Lot Number
Look for the lot numbers listed in the recall: S700038, S700044, S700059, S700065, S700410, S700427, S700617, S700619, S700813, S700815, S700869, S700871, S700873, S700875, S701073.
Questions people ask
Why is this medication being recalled?
The medication may have less active drug than specified, which could lead to ineffective treatment for urinary tract infections.
What should I do if I have this medication?
Check the lot number on your product. If it matches the recalled lots, contact Lupin Somerset for instructions.
Is this medication safe to use?
The recall is for potential reduced effectiveness, not safety risks. The medication is safe to use if it is not part of the recalled lots.
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-0346-2019 — Lupin Somerset Lupin Somerset Hello, I own a Lupin Somerset that is covered by recall D-0346-2019 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-0346-2019 (December 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0346-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.