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Unrated Drug recall · FDA · Published March 19, 2019

Lupin Recalls Gavilyte-N Packets Due to Labeling Error

Lupin Somerset recalls Gavilyte-N packets because orange and cherry flavors incorrectly list 'natural lemon flavor' as an ingredient.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1113-2019DrugLupin Somerset ›
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Contact the company

Recalling firmLUPIN SOMERSET400 Campus Dr · Somerset, NJ 08873-1145
✎ GovInfoNow plain-language explainer

Lupin Somerset is recalling specific lots of Gavilyte-N oral solution packets due to a labeling error. The orange and cherry flavor packets incorrectly list "natural lemon flavor" as an ingredient on the label. This recall affects approximately 76,422 bottles distributed nationwide. Read more at govinfonow.com/recall/39077-lupin-recalls-gavilyte-n-packets-due-to-labeling-error.

Source Summary by GovInfoNow · govinfonow.com/recall/39077-lupin-recalls-gavilyte-n-packets-due-to-labeling-error · Updated October 11, 2026 · FDA enforcement record: FDA #D-1113-2019

Cite this page

“Lupin Recalls Gavilyte-N Packets Due to Labeling Error.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39077-lupin-recalls-gavilyte-n-packets-due-to-labeling-error. Based on FDA recall #D-1113-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1113-2019%22&limit=1).

The FDA announced on March 19, 2019, that Lupin Somerset is recalling Gavilyte-N Oral Solution Packets due to labeling errors. The hazard involves incorrect ingredient lists for orange and cherry flavor packets. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Lupin Somerset
  • Product: Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only
  • UPC: 343386050192
  • UPC: 343386200023
  • UPC: 343386202027
  • UPC: 3433862034
  • Lot codes: S800021, S800175, S 800401, S800426, S800920

The hazard

The FDA stated that orange and cherry flavor packets incorrectly list "natural lemon flavor" as an ingredient. This labeling error constitutes the hazard for this Class II recall.

Context

GovInfoNow's records show Lupin Somerset has had eight other recalls on record since May 24, 2018. Other recent recalls include a March 19, 2019 Gavilyte-N recall, a April 10, 2019 Morphine Sulfate Tablets recall for impurities, and a January 15, 2019 Fluocinolone Acetonide Topical Solution recall due to impurities. Additional recent recalls include a December 21, 2018 Nitrofurantoin Oral Suspension recall for subpotent drug risk, a June 23, 2026 Glucagon Emergency Kit recall for CGMP deviation risk, an April 24, 2026 Liraglutide Injection recall for particulate matter hazard, and a November 13, 2025 Ganirelix Acetate Injection recall for impurity risk.

How to tell if you have this one

Check your Gavilyte-N packets for the following UPCs: 343386200023 (Lemon), 343386202027 (Orange), or 3433862034 (Cherry). Verify the lot numbers: S800021, S800175, S800401, S800426, or S800920. The expiration dates range from November 2020 to August 2021.

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

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3.2 years after the firm started it.

1. Firm started the recall: Mar 19, 201912. FDA classified it Class II: Apr 9, 201923. Published in FDA’s Enforcement Report: Apr 17, 201934. FDA terminated the recall: May 23, 2022420192022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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 qwen3.6:35b-a3b on October 11, 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