The Recall Desk
HighFDA (Drugs)·D-0233-2026·Announced 2025-12-24

Carbocaine Injectable Medication Recalled for Defective and Broken Cartridges

Novocol Pharmaceutical recalls Carbocaine 3% injectable solution due to cracked or broken cartridge containers that may compromise product integrity. The recall affects 40 cartons of lot D05159I distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an injectable drug with an actual defect (cracked/broken cartridges) that poses a risk of contamination and loss of product integrity. No illnesses or injuries are reported in the source. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Novocol Pharmaceutical of Canada, Inc. is recalling Carbocaine 3% (mepivacaine hydrochloride) injection nationwide in the United States. The product consists of single-dose cartridges containing 1.7 mL of solution, supplied in cartons of 50 cartridges each. The affected lot is D05159I, which expires July 31, 2027.

The recall was initiated due to a container defect: cartridges in the affected lot have cracked or broken walls. This defect may compromise the integrity and safety of the product.

The recall involves 40 cartons of the affected lot distributed nationwide. The recall affects healthcare providers and facilities that have received this product.

Healthcare providers with Carbocaine 3% from lot D05159I should discontinue use and consult with Novocol Pharmaceutical regarding the proper disposition of affected product. Patients who have received an injection from affected cartridges should contact their healthcare provider with any health concerns.

The recalled product

Product
CARBOCAINE (MEPIVACAINE HYDROCHLORIDE)
Brand
CARBOCAINE
Manufacturer
Novocol Pharmaceutical of Canada, Inc.
Hazard
  • defective-container
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: D05159I
  • expires: 07-31-2027

Distribution

Distributed nationwide across the United States.