Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution Recalled by Novel Laboratories, Inc. d.b.a LUPIN Due to Failed Stability Specification; Out of specification for Osmolarity

Date: July 29, 2021
Company: Novel Laboratories, Inc. d.b.a LUPIN
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 directly.

Affected Products

GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19

Quantity: 20,814 bottles

Why Was This Recalled?

Failed Stability Specification; Out of specification for Osmolarity

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

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

Related Recalls

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