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

Is NDC 52083-0630-16 recalled?

Pecgen Dmx · 474 mL in 1 BOTTLE, PLASTIC (52083-630-16)

Yes — this exact package was recalled

1 FDA recall names the code 52083-0630-16 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 HBr, Guaifenesin
Strength
DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL; GUAIFENESIN 187…
Form
Solution · Oral
Labeler
Kramer Novis
Type
Human OTC Drug
Product code
52083-0630

Recalls naming this package

Class I · High risk

Pecgen DMX Cough Suppressant Expectorant

Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.

Terminated Labeling / mix-up Novis PR, Inc. NDC 52083-630-16 D-1395-2019

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