Kids' Cough and Chest Congestion (Dextromethorphan HBr recall
FDA recall D-0034-2025 · initiated Sep 25, 2024
Denison Pharmaceuticals, LLC recalled Kids' Cough and Chest Congestion (Dextromethorphan HBr in Sep 2024 — an FDA Class III recall (D-0034-2025) because Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 105,048 bottles
Details
- Product
- Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018
- 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
Frequently asked
- Was Kids' Cough and Chest Congestion (Dextromethorphan HBr recalled?
- Denison Pharmaceuticals, LLC recalled Kids' Cough and Chest Congestion (Dextromethorphan HBr in Sep 2024 — an FDA Class III recall (D-0034-2025) because Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Kids' Cough and Chest Congestion (Dextromethorphan HBr recalled?
- Per the FDA enforcement record, the reason for recall D-0034-2025 was: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
- Is a recalled Kids' Cough and Chest Congestion (Dextromethorphan HBr dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Kids' Cough and Chest Congestion (Dextromethorphan HBr are affected?
- Distributed: Product was distributed to two accounts that may have distributed the product further to the Retail Level.. The recall covers these lots — Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0034-2025.