Reported Apr 17, 2019 · Terminated

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

Lupin Somerset

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: LUPIN SOMERSET · 400 Campus Dr · Somerset, NJ · 08873-1145

Is this the product you have?

3 of 3 products

Products covered by this recall
Model / numberProduct as published
343386200023Lemon Flavor Pack net wt. 2 g
343386202027Orange Flavor Pack net wt. 2 g
3433862034Cherry Flavor Pack net wt. 2 g
Lot codes and dates
    • Lot #: a) S800021
    • Exp 30-Nov-20
    • b) S800175
    • Exp 31-Dec-20
    • c) S 800401
    • Exp 28-Feb-21
    • S800426
    • Exp 31-Mar-21
    • S800920
    • Exp 31-Aug-21
Amount recalled
76422 bottles

Where it was sold

  • Nationwide

Why it was recalled

Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 23, 2022 · Data as of Sep 19, 7:23 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.