Novocol Pharmaceutical recalls
Novocol Pharmaceutical appears in 9 official U.S. recall notices indexed by RecallRadar, most recently on 2025-12-24.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 9 |
|---|---|
| Published | 2013-09-04 to 2025-12-24 |
| By agency | FDA Drug (9) |
| By classification | Class II (8), Class III (1) |
| By status | ongoing (7), terminated (2) |
| Distribution named in notices | US |
Recalls
- Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containin…
FDA Drug · Class II · 2025-12-24 · Novocol Pharmaceutical
Reason: Defective container: cracked/broken cartridges - Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP), packaged in a carton containing 50 Single-Dose Cartridges…
FDA Drug · Class II · 2025-12-24 · Novocol Pharmaceutical
Reason: Defective container: cracked/broken cartridges - Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Ca…
FDA Drug · Class II · 2025-12-24 · Novocol Pharmaceutical
Reason: Defective container: cracked/broken cartridges - OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton containing 10 cartridges, 0.4 mg/1.7mL, Rx only, Made in Ca…
FDA Drug · Class II · 2025-12-24 · Novocol Pharmaceutical
Reason: Defective container: cracked/broken cartridges - darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing…
FDA Drug · Class II · 2025-12-24 · Novocol Pharmaceutical
Reason: Defective container: cracked/broken cartridges - 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dos…
FDA Drug · Class II · 2025-12-24 · Novocol Pharmaceutical
Reason: Defective container: cracked/broken cartridges - 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dos…
FDA Drug · Class II · 2025-12-24 · Novocol Pharmaceutical
Reason: Defective container: cracked/broken cartridges - Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Ma…
FDA Drug · Class III · 2020-12-16 · Novocol Pharmaceutical
Reason: Labeling: Label mix-up - Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.…
FDA Drug · Class II · 2013-09-04 · Novocol Pharmaceutical
Reason: Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.