CLASS III Drug recall · Reported 24 Aug 2022 · FDA Enforcement Report
Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine recalled
Heron Therapeutics is recalling Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose, distributed nationwide in the US. The recall was initiated on 2 Aug 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1335-2022
- FDA event ID
- 90712
- Recalling firm
- Heron Therapeutics, San Diego, CA
- Brand
- Zynrelef
- Manufacturer
- Heron Therapeutics, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 2 Aug 2022
- FDA classified
- 12 Aug 2022
- Reported
- 24 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 2 Aug 2022 | Recall initiated by company | |
| 12 Aug 2022 | Classified by FDA | +10 days |
| 24 Aug 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
Which lots are affected?
Lot #: 01126739, Exp 7/31/2023
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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