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

Is NDC 52083-0660-16 recalled?

Sorbugen · 480 mL in 1 BOTTLE (52083-660-16)

Yes — this exact package was recalled

1 FDA recall names the code 52083-0660-16 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
dextromethorphan hydrobromide, glycerol guaiacolate
Strength
DEXTROMETHORPHAN HYDROBROMIDE 15 mg/7.5mL; GUAIFENESIN 150…
Form
Syrup · Oral
Labeler
Kramer Novis
Type
Human OTC Drug
Product code
52083-0660

Recalls naming this package

Class II · Moderate risk

Sorbugen Nr

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Terminated Stability / shelf life Pharma-Natural Inc. NDC 52083-660-16 D-1505-2019

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