The Recall Desk
ModerateFDA (Drugs)·D-0232-2026·Announced 2025-12-24

Mepivacaine anesthetic cartridges recalled nationwide for defective containers

Novocol Pharmaceutical is recalling mepivacaine anesthetic cartridges distributed nationwide due to defective containers with cracks or breaks. The recall affects lot D05159H.

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: FDA Class II drug recall with no reported illnesses or injuries. The defect involves container integrity of an injectable anesthetic, which poses a potential contamination risk. However, with no documented harm, this qualifies as a moderate-severity precautionary recall.

Plain-English summary

Novocol Pharmaceutical of Canada, Inc. is recalling Mepivacaine HCI 3% injection cartridges used in dental anesthesia. The product is supplied as single-dose cartridges containing 1.7 mL each, packaged in cartons of 50 units, and distributed by Benco Dental.

The recall is due to defective containers. Certain cartridges in the affected lot have cracks or breaks, which compromise the container integrity and sterility assurance of the product.

The recalled lot is number D05159H with an expiration date of July 31, 2027. This lot was distributed nationwide throughout the United States to dental offices and healthcare facilities.

The recalled product

Product
MEPIVACAINE (MEPIVACAINE HYDROCHLORIDE)
Brand
MEPIVACAINE
Manufacturer
Novocol Pharmaceutical of Canada, Inc.
Category
Drug — Injectable / Local Anesthetic
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: D05159H
  • expires: 07-31-2027

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · MEPIVACAINE

Same category