Class IITerminated

Henry Schein recall

FDA recall D-0148-2025 · initiated Nov 14, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Details

Product: Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,
Recalling company: Keystone Industries
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
Initiated: Nov 14, 2024
FDA report date: Dec 25, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0148-2025 ↗

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