Reported Dec 24, 2025 · Ongoing
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton…
Novocol Pharmaceutical of Canada, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novocol Pharmaceutical of Canada, Inc. · 25 Wolseley Crt · Cambridge · N/A
Is this the product you have?
- 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Dentsply Pharmaceutical, York, PA 17404, by Novocol Pharmaceutical of Canada, Inc., NDC 66312-441-16.
- Lot codes and dates
- LotD05159C
- expires07-31-2027
- Amount recalled
- 5,825
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Defective container: cracked/broken cartridges
This product could cause temporary or reversible health problems — stop using it.
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