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.
Related recalls
Same brand · MEPIVACAINE
- ModerateMepivacaine anesthetic cartridges recalled nationwide for defective containers
FDA (Drugs) · 2025-12-24
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27