Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 0116-2001-16 recalled?

Chlorhexidine Gluconate · 473 mL in 1 BOTTLE (0116-2001-16)

Yes — this exact package was recalled

2 FDA recalls name the code 0116-2001-16 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
Chlorhexidine Gluconate
Strength
CHLORHEXIDINE GLUCONATE 1.2 mg/mL
Form
Rinse · Oral
Labeler
Xttrium Laboratories, Inc.
Type
Human Prescription Drug
Product code
0116-2001

Recalls naming this package

Class II · Moderate risk

Chlorhexidine 0.12% liquid

Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).

Terminated Labeling / mix-up Prescript Pharmaceuticals, Inc. D-0807-2018

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.