Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Calcium Hydroxide Powder Recalled by Axcentria Pharmaceuticals, LLC Due to One lot of Calcium Hydroxide Powder is being...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Axcentria Pharmaceuticals, LLC directly.
Affected Products
Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.
Quantity: 528
Why Was This Recalled?
One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use.
Where Was This Sold?
This product was distributed to 2 states: CA, NY
About Axcentria Pharmaceuticals, LLC
Axcentria Pharmaceuticals, LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report