Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

PEG-3350 Recalled by Novel Laboratories, Inc. d.b.a Lupin Somerset Due to Defective container: potential for non-sealed pouches which can...

Date: July 2, 2024
Company: Novel Laboratories, Inc. d.b.a Lupin Somerset
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Novel Laboratories, Inc. d.b.a Lupin Somerset directly.

Affected Products

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.

Quantity: 13,200 cartons

Why Was This Recalled?

Defective container: potential for non-sealed pouches which can lead to product leakage.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Novel Laboratories, Inc. d.b.a Lupin Somerset

Novel Laboratories, Inc. d.b.a Lupin Somerset has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report