Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

National Drug Code

Is NDC 43386-0050-19 recalled?

Gavilyte-N · 438.4 g in 1 BOTTLE (43386-050-19)

Yes — this exact package was recalled

1 FDA recall names the code 43386-0050-19 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
polyethylene glycol-3350, sodium chloride, potassium chloride and sodium bicarbonate
Strength
POLYETHYLENE GLYCOL 3350 420 g/438.4g; SODIUM CHLORIDE 11.2…
Form
Powder, for Solution · Oral
Labeler
Lupin Pharmaceuticals,Inc.
Type
Human Prescription Drug
Product code
43386-0050

Recalls naming this package

Class II · Moderate risk

Gavilyte-N

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

Terminated Labeling / mix-up Lupin Somerset NDC 43386-050-19 D-1113-2019

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler