Benco dental Graham CHEMICAL CO. recall
FDA recall D-0232-2026 · initiated Oct 31, 2025
Novocol Pharmaceutical of Canada, Inc. recalled Benco dental Graham CHEMICAL CO. in Oct 2025 — an FDA Class II recall (D-0232-2026) because Defective container: cracked/broken cartridges.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective container: cracked/broken cartridges
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- Product
- Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Cartridges, 1.7 mL each, Rx only, Distributed by Benco Dental 295 Center Point Blvd, Pittston, PA 18640, Manufactured by Novocol Pharmaceutical of Canada, Inc., NDC 66975-406-51.
- Recalling company
- Novocol Pharmaceutical of Canada, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S.A. Nationwide
- Initiated
- Oct 31, 2025
- FDA report date
- Dec 24, 2025
Frequently asked
- Was Benco dental Graham CHEMICAL CO. recalled?
- Novocol Pharmaceutical of Canada, Inc. recalled Benco dental Graham CHEMICAL CO. in Oct 2025 — an FDA Class II recall (D-0232-2026) because Defective container: cracked/broken cartridges. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Benco dental Graham CHEMICAL CO. recalled?
- Per the FDA enforcement record, the reason for recall D-0232-2026 was: Defective container: cracked/broken cartridges
- Is a recalled Benco dental Graham CHEMICAL CO. dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Benco dental Graham CHEMICAL CO. are affected?
- Distributed: U.S.A. Nationwide. The recall covers these lots — Lot: D05159H, expires: 07-31-2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0232-2026.