Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Dextromethorphan recalled?

Yes — there is an active recall. 6 ongoing FDA recalls mention Dextromethorphan (73 total). Check the affected lots below.

Most common reason: cGMP deviation (13 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Dextromethorphan. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Dextromethorphan recalls on record

none so far in 2026; 73 on record, newest first
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
Class II · Moderate risk

Premier Value Tussin Cough DM

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

Ongoing Microbial contamination Seaway Pharma Inc. D-0215-2024
Class II · Moderate risk

Safe tussin PM

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Ongoing cGMP deviation Denison Pharmaceuticals, LLC D-0775-2023
Class II · Moderate risk

Safe tussin DM

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Ongoing cGMP deviation Denison Pharmaceuticals, LLC D-0772-2023
Class I · High risk

G-Supress DX

Product mix-up: incorrect product was found inside the G-Supress DX product carton.

Terminated Labeling / mix-up Novis PR, LLC dba Kramer Novis NDC 52083-655-01 D-0868-2023
Class III · Low risk

Wal-Tussin DM

Incorrect/Undeclared Excipient: Product contains alcohol

Terminated Chemical / undeclared AptaPharma Inc. NDC 0363-0324-28 D-0787-2022
Class II · Moderate risk

Chloresin

cGMP deviations

Terminated cGMP deviation Ultra Seal Corporation NDC 51532-0107-2 D-0468-2022
Class II · Moderate risk

Brompheniramine Maleate

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 60432-275-16 D-0596-2021