Gavilyte-N Recalled for Incorrect Flavor Labeling on Orange and Cherry Packets
Lupin Somerset is recalling Gavilyte-N because orange and cherry flavor packets incorrectly list 'natural lemon flavor' as an ingredient.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is a labeling error with no reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Lupin Somerset is recalling Gavilyte-N (Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate) for Oral Solution. The recall involves 76,422 bottles distributed nationwide. The specific issue is a labeling error where the orange and cherry flavor packets incorrectly list "natural lemon flavor" as an ingredient.
The recall is classified as FDA Class II. The source text does not report any illnesses or injuries associated with this labeling error. The affected lots include S800021, S800175, S800401, S800426, and S800920, with expiration dates ranging from November 2020 to August 2021.
Consumers should check their Gavilyte-N bottles for the affected lot numbers and flavor packets. If the orange or cherry flavor packets list "natural lemon flavor," they should stop using the product and contact the manufacturer or their healthcare provider for instructions.
The recalled product
- Product
- GAVILYTE-N (POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE)
- Brand
- GAVILYTE-N
- Manufacturer
- LUPIN SOMERSET
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 76,422
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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.
UPCs (3)
- 343386050192
- 343386200023
- 343386202027
Distribution
Distributed nationwide across the United States.
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