Medications & Supplements/Prescription Drugs

Novocol Dental Injectables Recalled for Cracked or Broken Cartridges

Agency Publication Date: December 12, 2025

Summary

Novocol Pharmaceutical of Canada, Inc. has voluntarily recalled 43,843 units of various dental anesthetic cartridges, including Xylocaine (lidocaine), Polocaine (mepivacaine), and OraVerse (phentolamine mesylate). The recall was initiated because the glass cartridges may be cracked or broken, which could compromise the sterility of the medication or lead to glass particles being injected or handled. These products were distributed nationwide in the United States and are commonly used in dental procedures for local anesthesia or to reverse its effects.

Risk

Cracked or broken cartridges can lead to a loss of sterility, potentially causing infections at the injection site. Additionally, there is a risk of physical injury or the injection of glass fragments into the patient during the dental procedure.

What You Should Do

Identify if you have the affected products by checking the lot numbers and expiration dates on the outer carton or individual cartridges. The affected products include Xylocaine 2%, Polocaine 3%, Mepivacaine HCI 3%, Carbocaine 3%, and OraVerse.
Check for the following specific lot numbers and expiration dates: Xylocaine (Lot D05337B, Exp 06-30-2027), Lidocaine HCI 2% (Lot D05362A, Exp 07-31-2027), Polocaine 3% (Lot D05159C, Exp 07-31-2027), Mepivacaine HCI 3% (Lots D05159G and D05159H, both Exp 07-31-2027), Carbocaine 3% (Lot D05159I, Exp 07-31-2027), and OraVerse (Lot D05004E, Exp 04-30-2027).
Stop using the recalled product immediately to prevent patient injury or infection.
Contact Novocol Pharmaceutical of Canada, Inc. or your specific distributor (such as Dentsply, Patterson Dental, Darby Dental, Benco Dental, or Septodont) to arrange for the return of the affected cartridges.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report any adverse events.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP)

Variants: 1.7 mL single-dose cartridges, 50 cartridges per carton

Lot Numbers:

D05337B (Exp 06-30-2027)

NDC:

66312-176-16

Manufactured for Dentsply Pharmaceutical.

Product: Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP)

Variants: 1.7 ml single-dose cartridges, 50 cartridges per carton

Lot Numbers:

D05362A (Exp 07-31-2027)

NDC:

50227-1030-5

Manufactured for Patterson Dental Supply, Inc.

Product: 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP)

Variants: 1.7 ml single-dose cartridges, 50 cartridges per carton

Lot Numbers:

D05159C (Exp 07-31-2027)

NDC:

66312-441-16

Manufactured for Dentsply Pharmaceutical.

Product: Darby Dental Supply Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP]

Variants: 1.7 mL single-dose cartridges, 50 cartridges per carton

Lot Numbers:

D05159G (Exp 07-31-2027)

NDC:

66467-9760-5

Distributed by Darby Dental Supply.

Product: Benco Dental Graham Chemical Co. Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP]

Variants: 1.7 mL single-dose cartridges, 50 cartridges per carton

Lot Numbers:

D05159H (Exp 07-31-2027)

NDC:

66975-406-51

Distributed by Benco Dental.

Product: Cook-Waite Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP)

Variants: 1.7 mL single-dose cartridges, 50 cartridges per carton

Lot Numbers:

D05159I (Exp 07-31-2027)

NDC:

0362-0753-05

Brand name Cook-Waite.

Product: OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL

Variants: 1.7mL cartridges, 10 cartridges per carton

Lot Numbers:

D05004E (Exp 04-30-2027)

NDC:

0362-0101-10

Distributed by Septodont, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98080

Status: Active

Manufacturer: Novocol Pharmaceutical of Canada, Inc.

Sold By: Dentsply Pharmaceutical; Patterson Dental Supply, Inc.; Darby Dental Supply; Benco Dental; Septodont, Inc.

Manufactured In: Canada

Units Affected: 6 products (18,789 cartons- 50 cartridges /carton; 12,033 cartons; 5,825; 5,520 Cartons; 40 cartons; 1,636 cartons)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected products by checking the lot numbers and expiration dates on the outer carton or individual cartridges. The affected products include Xylocaine 2%, Polocaine 3%, Mepivacaine HCI 3%, Carbocaine 3%, and OraVerse.

Check for the following specific lot numbers and expiration dates: Xylocaine (Lot D05337B, Exp 06-30-2027), Lidocaine HCI 2% (Lot D05362A, Exp 07-31-2027), Polocaine 3% (Lot D05159C, Exp 07-31-2027), Mepivacaine HCI 3% (Lots D05159G and D05159H, both Exp 07-31-2027), Carbocaine 3% (Lot D05159I, Exp 07-31-2027), and OraVerse (Lot D05004E, Exp 04-30-2027).

Stop using the recalled product immediately to prevent patient injury or infection.

Contact Novocol Pharmaceutical of Canada, Inc. or your specific distributor (such as Dentsply, Patterson Dental, Darby Dental, Benco Dental, or Septodont) to arrange for the return of the affected cartridges.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report any adverse events.

Affected Products

Product: 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP)

Variants: 1.7 mL single-dose cartridges, 50 cartridges per carton

Lot Numbers:

D05337B (Exp 06-30-2027)

NDC:

66312-176-16

Manufactured for Dentsply Pharmaceutical.

Product: Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP)

Variants: 1.7 ml single-dose cartridges, 50 cartridges per carton

Lot Numbers:

D05362A (Exp 07-31-2027)

NDC:

50227-1030-5

Manufactured for Patterson Dental Supply, Inc.

Product: 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP)

Variants: 1.7 ml single-dose cartridges, 50 cartridges per carton

Lot Numbers:

D05159C (Exp 07-31-2027)

NDC:

66312-441-16

Manufactured for Dentsply Pharmaceutical.

Product: Darby Dental Supply Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP]

Variants: 1.7 mL single-dose cartridges, 50 cartridges per carton

Lot Numbers:

D05159G (Exp 07-31-2027)

NDC:

66467-9760-5

Distributed by Darby Dental Supply.

Product: Benco Dental Graham Chemical Co. Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP]

Variants: 1.7 mL single-dose cartridges, 50 cartridges per carton

Lot Numbers:

D05159H (Exp 07-31-2027)

NDC:

66975-406-51

Distributed by Benco Dental.

Product: Cook-Waite Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP)

Variants: 1.7 mL single-dose cartridges, 50 cartridges per carton

Lot Numbers:

D05159I (Exp 07-31-2027)

NDC:

0362-0753-05

Brand name Cook-Waite.

Product: OraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL

Variants: 1.7mL cartridges, 10 cartridges per carton

Lot Numbers:

D05004E (Exp 04-30-2027)

NDC:

0362-0101-10

Distributed by Septodont, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98080

Status: Active

Manufacturer: Novocol Pharmaceutical of Canada, Inc.

Sold By: Dentsply Pharmaceutical; Patterson Dental Supply, Inc.; Darby Dental Supply; Benco Dental; Septodont, Inc.

Manufactured In: Canada

Units Affected: 6 products (18,789 cartons- 50 cartridges /carton; 12,033 cartons; 5,825; 5,520 Cartons; 40 cartons; 1,636 cartons)

Distributed To: Nationwide