Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack
CGMP Deviations: Released product should have been rejected.
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.
CGMP Deviations: Released product should have been rejected.
Failed Impurity/Degradation Specifications
Failed Impurity/Degradation Specifications
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
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.
Microbial Contamination of Non-Sterile Products
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Incorrect/Undeclared Excipient: Product contains alcohol
CGMP Deviations
CGMP Deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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