# FDA recall D-1335-2022

> **HERON THERAPEUTICS, INC.** · Class III · drug recall initiated 2022-08-02.

## Product

Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02

## Reason for recall

Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1335-2022
- **Recalling firm:** HERON THERAPEUTICS, INC.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-08-02
- **Report date:** 2022-08-24
- **Termination date:** 2023-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1335-2022

## Citation

> AI Analytics. FDA recall D-1335-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/D-1335-2022. Source: US FDA. Licensed CC0.

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