CLASS II Drug recall · Reported 4 Sep 2013 · FDA Enforcement Report
Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection recalled
Novocol Pharmaceutical of Canada is recalling Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, distributed nationwide in the US. The recall was initiated on 14 Aug 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-923-2013
- FDA event ID
- 65979
- Recalling firm
- Novocol Pharmaceutical of Canada, Cambridge
- Brand
- Lidocaine
- Manufacturer
- Darby Dental Supply, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Aug 2013
- FDA classified
- 26 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 14 Aug 2013 | Recall initiated by company | |
| 26 Aug 2013 | Classified by FDA | +12 days |
| 4 Sep 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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, made in Canada, 42756-1030-5; Manufactured by: by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3.
Where it was distributed
Nationwide and Canada
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #s: D00290 D, Exp 08/2013; D00205 A, Exp 11/2013
Where was it sold?
Nationwide and Canada
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Novocol Pharmaceutical of Canada
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine HCI 2% and Epinephrine 1:100 recalledLidocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | Cook-Walte, Carbocaine 3% (30 mg/mL) recalledCarbocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg recalledOraverse | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | 2% Xylocaine Dental with Epinephrine 1:100 recalledXylocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
| Drug | CLASS II | 3% Polocaine Dental, Mepivacaine Hydrochloride 3% (30mg/mL) recalledPolocaine | Novocol Pharmaceutical of Canada | Packaging Defects | Nationwide |
Other Lidocaine recalls
All 119| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Lidolog Kit, Kit Contains: Lidocaine HCl Injection recalledLidolog Kit | Asclemed USA | Other | TN |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection USP, 1% (10 mg/mL) single dose ampule recalledLidocaine Hydrochloride | Asclemed USA | Sterility | Nationwide |