Gavilyte-N (Lupin Somerset) – Incorrect Flavor Labeling (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD NDC 43386-050-19 UPC 343386050192 a) Lemon Flavor Pack net wt. 2 g UPC 343386200023 b) Orange Flavor Pack net wt. 2 g UPC 343386202027 c) Cherry Flavor Pack net wt. 2 g UPC 3433862034
Brand
LUPIN SOMERSET
Lot Codes / Batch Numbers
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.
Products Sold
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.
LUPIN SOMERSET is recalling Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, due to Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026