CLASS II Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report

Gavilyte-N, PEG-3350, Sodium chloride recalled by Lupin Somerset

Lupin Somerset is recalling Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral, distributed nationwide in the US. The recall was initiated on 19 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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.

NDC43386-050

UPC343386050192, 343386200023, 343386202027

Quantity recalled76422 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1113-2019
FDA event ID: 82396
Recalling firm: Lupin Somerset, Somerset, NJ
Brand: Gavilyte-n
Manufacturer: Lupin Pharmaceuticals,Inc.
Classification: Class II
Status: Terminated
Recall initiated: 19 Mar 2019
FDA classified: 9 Apr 2019
Reported: 17 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Stomach & Acid Reflux Medication

Timeline

19 Mar 2019	Recall initiated by company
9 Apr 2019	Classified by FDA	+21 days
17 Apr 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Lupin Somerset

All 13

Reported	Class	Recall	Company	Reason	Where
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 30 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 15 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 200 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide
1 May 2019Drug	CLASS III	Morphine Sulfate Extended-Release Tablets, 60 mg recalledMorphine Sulfate	Lupin Somerset	Potency & Assay	Nationwide

Other Polyethylene Glycol-3350 recalls

All 5

Reported	Class	Recall	Company	Reason	Where
17 Aug 2022Drug	CLASS II	Miralax (Polyethylene Glycol 3350), Powder for Solution recalledMiralax	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
25 May 2022Drug	CLASS II	GaviLyte -C (Polyethylene Glycol 3350 and electrolytes recalledGavilyte - C	Lupin Pharmaceuticals	Potency & Assay	Nationwide
25 Aug 2021Drug	CLASS II	GaviLyteTM - C PEG-3350 and Electrolytes for Oral Solution recalledGavilyte - C	Novel Laboratories Inc. d.b.a Lupin	Potency & Assay	Nationwide
16 May 2018Drug	CLASS II	Polyethylene Glycol 3350, powder, for solution BRE recalled	Kroger Specialty Pharmacy	Other	5 states