FDA Recall D-0228-2026

Novocol Pharmaceutical of Canada, Inc.

Class II Ongoing 195 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose cartridges, 1.7 mL each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-176-16.

Lot / code: Lot: D05337B, expires: 06-30-2027

Quantity: 18,789 cartons- 50 cartridges /carton

Reason for recall

Defective container: cracked/broken cartridges

Recall record

Recall number: D-0228-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S.A. Nationwide
Recall initiated: 2025-10-31
Classified by FDA Center: 2025-12-12
FDA published: 2025-12-24
Recalling firm: Novocol Pharmaceutical of Canada, Inc.

Drug identification

Brand name(s): XYLOCAINE
Generic name(s): LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
Manufacturer(s): Dentsply Pharmaceutical
NDC(s): 66312-176, 66312-181
Route(s): SUBMUCOSAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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