# FDA recall D-0228-2026

> **Novocol Pharmaceutical of Canada, Inc.** · Class II · drug recall initiated 2025-10-31.

## 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 for recall

Defective container: cracked/broken cartridges

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0228-2026
- **Recalling firm:** Novocol Pharmaceutical of Canada, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-31
- **Report date:** 2025-12-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0228-2026

## Citation

> AI Analytics. FDA recall D-0228-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0228-2026. Source: US FDA. Licensed CC0.

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