Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Presence of Foreign Tablets/Capsules
Yes — there is an active recall. 20 ongoing FDA recalls mention Pyridoxine (72 total). Check the affected lots below.
Most common reason: Sterility / contamination (58 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pyridoxine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Presence of Foreign Tablets/Capsules
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Presence of Particulate Matter.
Presence of Particulate Matter.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Lack of assurance of sterility.
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Sterility Assurance.
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