Class III · Low risk
Guaifenesin and Codeine Phosphate Oral Solution USP
Superpotent; sodium benzoate preservative
Is Guaifenesin recalled?
Yes — there is an active recall. 7 ongoing FDA recalls mention Guaifenesin (78 total). Check the affected lots below.
Most common reason: cGMP deviation (21 of these recalls)
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
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack
CGMP Deviations: Released product should have been rejected.
Class II · Moderate risk
Guaifenesin Dextromethorphan Syrup
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Guaifenesin Dextromethorphan Syrup
Failed Impurity/Degradation Specifications
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.
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.
Class II · Moderate risk
Broncochem Cold & Flu Syrup Kids
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
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.
Class II · Moderate risk
Safe Tussin DM Cough + Chest Congestion
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Safe tussin DM
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II · Moderate risk
Guaifenesin Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Guaiatussin AC Sugar-Free
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class I · High risk
G-Supress DX
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Class III · Low risk
NDC 0363-6171-09 Walgreens Sinus Pressure
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class II · Moderate risk
CORRECTDOSE Children's COUGH & CHEST CONGESTION DM
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class III · Low risk
Wal-Tussin DM
Incorrect/Undeclared Excipient: Product contains alcohol
Class II · Moderate risk
Ephedrine 25 Guaifenesin 200 Tablet
CGMP Deviations
Class II · Moderate risk
Kramer Novis Tusicof Caplet
CGMP Deviations
Class II · Moderate risk
Zee Cold Tabs
CGMP Deviations
Class II · Moderate risk
4-Component Cold Tabs
CGMP Deviations
Class II · Moderate risk
3-Component Cold Tabs
CGMP Deviations
Class II · Moderate risk
Sinus Relief
cGMP deviations
Class II · Moderate risk
Cetafen Cough & Cold Cough & Cold Relief
cGMP deviations
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