Recall

Could cause harm

Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP…

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

Official FDA data record

What to do

Does your product match this recall?

Scan your barcode or label to compare your product with this notice. We’ll help you check the lot or date code when needed.

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  1. 1Compare the product, size and lot or date code with this notice.
  2. 2If your product matches, stop using it and follow the official recall instructions.
  3. 3Read the official notice for return, refund or disposal instructions.

Recall details

Firm
Denison Pharmaceuticals, LLC
Status
Ongoing
Reported
Nov 13, 2024
Started
Sep 25, 2024
Where sold
Product was distributed to two accounts that may have distributed the product further to the Retail Level.
Quantity
105,048 bottles
Notice number
D-0273-2025

Lots, UPC, dates

Lot #: 9762, Exp. Date 2/28/2025; 9763, 9764, 9765, Exp. Date 3/31/2025; 9869, 9870, Exp. Date 5/31/2025; 9871, 9872, Exp. Date 7/31/2025; 9996, 9997, 9998, Exp. Date 8/31/2025; 9995, Exp. Date 10/31/2025; 0154, 0153, 0326, Exp. Date 1/31/2026; 0155, 0156, 0161, 0327, 0329, 0328, Exp. Date 2/28/2026; 0479, 0480, Exp. Date 5/31/2026.

Agency wording

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

Source: FDA OTC report. This is not medical advice. Compare your package codes before you act.