The Recall Desk
ModerateFDA (Drugs)·D-0231-2026·Announced 2025-12-24

Mepivacaine injection recalled for defective cracked cartridges

Novocol Pharmaceutical is recalling Mepivacaine HCI 3% injection nationwide due to defective cartridges that may be cracked or broken.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II FDA drug recall for defective cartridges with no reported illnesses or injuries. Defective pharmaceutical packaging without reported harm is classified as Moderate severity.

Plain-English summary

Novocol Pharmaceutical of Canada, Inc. is recalling Mepivacaine HCI 3% (30mg/mL) injection in a nationwide recall. The reason for the recall is defective packaging: cartridges in the affected lot may be cracked or broken.

This recall affects 5,520 cartons of Mepivacaine distributed in the United States. The affected lot is D05159G (expiration date 07-31-2027). The product is a prescription-only local anesthetic administered by injection.

Dentists and healthcare providers should stop using the affected product immediately. Those who have dispensed or used product from this lot should contact Novocol or their supplier for instructions on returning the defective medication.

The recalled product

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

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: D05159G
  • expires: 07-31-2027

Distribution

Distributed nationwide across the United States.

Same brand · MEPIVACAINE