Class III · Low risk
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Presence of Foreign Tablets/Capsules
Is Doxylamine recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Doxylamine (7 total). Check the affected lots below.
Most common reason: cGMP deviation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Doxylamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Doxylamine recalls in 2026
1 initiated in 2026, 7 in total — 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
Safe tussin PM
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class III · Low risk
Nighttime Sleep-Aid
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Class II · Moderate risk
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Class II · Moderate risk
Vicks NyQuil Cold and Flu Nighttime Relief
Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.
Class II · Moderate risk
DayQuil Sinex DayTime Sinus Relief
Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.
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