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Drug recall · FDA · Published March 19, 2019

LUPIN SOMERSET recalls Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only,

Lupin Somerset recalls Gavilyte-N oral solutions with incorrect lemon flavor labeling. The product lists "natural lemon flavor" but should be orange or cherry. No immediate action needed as it's a labeling error.

🇺🇸 FDA recall #D-1113-2019DrugLupin Somerset ›
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Contact the company & request your remedy

Recalling firmLUPIN SOMERSET400 Campus Dr, N/A · 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 Gavilyte-N oral solutions that incorrectly list "natural lemon flavor" as an ingredient. This is a labeling error, not a safety hazard, so no action is required. Read more at govinfonow.com/recall/39077-lupin-somerset-gavilyte-n-oral-solution-incorrect-lemon-flavor-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/39077-lupin-somerset-gavilyte-n-oral-solution-incorrect-lemon-flavor-labeling · Updated October 5, 2026 · FDA enforcement record: FDA #D-1113-2019

Cite this page

“Lupin Somerset Gavilyte-N Oral Solution: Incorrect Lemon Flavor Labeling.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39077-lupin-somerset-gavilyte-n-oral-solution-incorrect-lemon-flavor-labeling. Based on FDA recall #D-1113-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1113-2019%22&limit=1).

Why it’s dangerous

The product incorrectly lists "natural lemon flavor" as an ingredient when it should be orange or cherry flavor. This is a labeling error, not a safety hazard.

Who’s affected

People who have the Gavilyte-N oral solution with the incorrect lemon flavor labeling. The risk is minimal as it's a labeling error, not a safety issue.

How to tell if you have this one

Check for Gavilyte-N oral solutions with UPC codes 343386200023 (lemon), 343386202027 (orange), or 3433862034 (cherry). The product has a specific lot number and expiration date.

  • Brand
    Lupin Somerset
  • Product
    Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Labeling

    Look for the label that lists "natural lemon flavor" as an ingredient instead of orange or cherry.

✎ GovInfoNow

Questions people ask

Is this product dangerous?

No, this is a labeling error, not a safety hazard. No action is needed.

What should I do if I have this product?

No action is required as it's a labeling error, not a safety issue.

How can I tell if I have the recalled product?

Check for Gavilyte-N oral solutions with UPC codes 343386200023 (lemon), 343386202027 (orange), or 3433862034 (cherry).

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-1113-2019 — Lupin Somerset Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for

Hello,

I own a Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only that is covered by recall D-1113-2019 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-1113-2019 (March 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1113-2019 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.
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