Class II · Moderate risk
COLD TERMINATOR decongestant/cold relief
cGMP deviations
Is Guaifenesin recalled?
Yes — there is an active recall. 7 ongoing FDA recalls mention Guaifenesin (78 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Guaifenesin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Guaifenesin recalls on record
none so far in 2026; 78 on record, newest first
Class II · Moderate risk
Cold Relief
cGMP deviations
Class II · Moderate risk
Cold Relief Severe Pain/Cough
cGMP deviations
Class II · Moderate risk
Multi Symptom Cold Relief
cGMP deviations
Class II · Moderate risk
Ephedrine Plus
cGMP deviations
Class II · Moderate risk
Chloresin
cGMP deviations
Class II · Moderate risk
AERO TAB Cold Relief
cGMP deviations
Class II · Moderate risk
Class III · Low risk
Mucus Relief D
Subpotent drug
Class II · Moderate risk
Childrens Robitussin Honey Cough and Chest Congestion DM
Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
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.
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.
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.
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.
Class II · Moderate risk
Robafen DM
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Extra Action Cough Syrup
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Cough Syrup
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Guaifenesin DAC Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Guaifenesin AC Cough Syrup
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Robafen DM Cough Sugar-Free Clear Cough Expectorant
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Robafen DM Syrup
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Robafen AC Oral Solution
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
Robafen Cough Formula Expectorant
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Class II · Moderate risk
CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
DrKids Children's Cough & Chest Congestion DM
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
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