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

Is NDC 69676-0077-09 recalled?

Cough and Chest Congestion Maximum Strength · 177 mL in 1 BOTTLE, PLASTIC (69676-0077-9)

Yes — this exact package was recalled

2 FDA recalls name the code 69676-0077-09 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.

2 of these recalls are still ongoing.

Active ingredient
Dextromethorphan HBr, Guaifenesin
Strength
GUAIFENESIN 400 mg/20mL; DEXTROMETHORPHAN HYDROBROMIDE 20…
Form
Suspension · Oral
Labeler
Genexa Inc.
Type
Human OTC Drug
Product code
69676-0077

Recalls naming this package

Class III · Low risk

Kids' Cough and Chest Congestion

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

Ongoing Failed specification Denison Pharmaceuticals, LLC D-0034-2025
Class III · Low risk

Adult Cough and Chest Congestion

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

Ongoing Failed specification Denison Pharmaceuticals, LLC D-0033-2025

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.