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.

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 II · Moderate risk

Theraflu Cough Relief

Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.

Terminated Labeling / mix-up GSK Consumer Health, Inc D-0996-2020
Class II · Moderate risk

Neogen-D

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Terminated Stability / shelf life Pharma-Natural Inc. NDC 52083-699-16 D-1506-2019
Class II · Moderate risk

Sorbugen Nr

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Terminated Stability / shelf life Pharma-Natural Inc. NDC 52083-660-16 D-1505-2019
Class II · Moderate risk

Tusslin

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Terminated Stability / shelf life Pharma-Natural Inc. NDC 52083-622-16 D-1504-2019
Class II · Moderate risk

Double Tussin Dm

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Terminated Stability / shelf life Pharma-Natural Inc. NDC 63708-121-04 D-1498-2019
Class II · Moderate risk

Gencontuss

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Terminated Stability / shelf life Pharma-Natural Inc. NDC 52083-650-16 D-1497-2019
Class II · Moderate risk

Robafen DM

CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Terminated Microbial contamination Preferred Pharmaceuticals, Inc NDC 68788-0841-01 D-1410-2019
Class II · Moderate risk

Extra Action Cough Syrup

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Terminated Microbial contamination Torrent Pharma Inc D-1369-2019
Class II · Moderate risk

Robafen DM Syrup

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Terminated Microbial contamination Torrent Pharma Inc D-1351-2019
Class II · Moderate risk

Guaifenesin DM Cherry liquid

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

Terminated Packaging defect Perrigo Company PLC NDC 49348-828-34 D-0587-2016
Class II · Moderate risk

Mucinex Fast Max DM Max

Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.

Terminated Labeling / mix-up Reckitt Benckiser LLC NDC 63824-019-66 D-1369-2015
Class I · High risk

Mucinex Fast Max Severe Congestion & Cough

Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.

Terminated Labeling / mix-up Reckitt Benckiser LLC NDC 63824-014-66 D-1367-2015
Class I · High risk

Mucinex Fast Max Cold

Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.

Terminated Labeling / mix-up Reckitt Benckiser LLC NDC 63824-015-66 D-1363-2015
Class III · Low risk

Mucinex DM

Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch

Terminated Packaging defect Reckitt Benckiser LLC NDC 63824-056-72 D-0964-2015