Lidocaine Hydrochloride Injection (Novocol) – Subpotent Drug (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each, NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO, 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3, 0362-9023-05; b) Superdent, Dist by: Darby Dental Supply Co., Jericho, NY 11753, Made in Canada, 66467-9730-5; and c) Dist by: IQ Dental, 353 Rt 46 W, Bldg C Unit 120, Fairfield, NJ, 07004, m
Brand
Novocol Pharmaceutical of Canada
Lot Codes / Batch Numbers
Lot #s: D00290 D, Exp 08/2013, D00205 A, Exp 11/2013
Products Sold
Lot #s: D00290 D, Exp 08/2013; D00205 A, Exp 11/2013
Novocol Pharmaceutical of Canada is recalling Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infilt due to Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, m. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026