FDA Drug recall D-0228-2026
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
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class II recall of 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dos… by Novocol Pharmaceutical, citing defective container: cracked/broken cartridges.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0228-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-31 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novocol Pharmaceutical |
| Distribution | US |
Product
2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine 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 66312-176-16.
Reason
Defective container: cracked/broken cartridges
Identifiers
| ndc | 66312-181-16 |
|---|---|
| ndc | 66312-176-16 |
| code_info | Lot: D05337B, expires: 06-30-2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2025-12-24 · Novocol Pharmaceutical - 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 - 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 - 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
All Novocol Pharmaceutical recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0228-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.