Class IIIOngoing

Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg recall

FDA recall D-0033-2025 · initiated Sep 25, 2024

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

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

Details

Product: Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155
Recalling company: Denison Pharmaceuticals, LLC
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Initiated: Sep 25, 2024
FDA report date: Nov 13, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0033-2025 ↗

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