Zynrelef — Class III drug recall D-1335-2022
Terminated recall by HERON THERAPEUTICS, INC., reported 2022-08-24, distributed nationwide. Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400
| Recall number | D-1335-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HERON THERAPEUTICS, INC., San Diego, CA, United States |
| Recall initiated | 2022-08-02 |
| Classified | 2022-08-12 |
| Reported by FDA | 2022-08-24 |
| Terminated | 2023-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,790 kits |
| NDC | 47426-0301, 47426-0301-02, 47426-0301-04, 47426-0301-06, 47426-0302, 47426-0302-02, 47426-0302-04, 47426-0302-06, 47426-0303, 47426-0303-01, 47426-0303-03, 47426-0303-05, 47426-0304, 47426-0304-01, 47426-0304-03, 47426-0304-05, 47426-0501, 47426-0501-02, 47426-0501-04, 47426-0502, 47426-0502-02, 47426-0502-04, 47426-0503, 47426-0503-01, 47426-0503-03 and 3 more |
| Lot numbers | 01126739 |
| Expiration dates | 2023-07-31 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1335-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.