Drug Recall: Incorrect Syringe in ZYNRELEF Anesthetic Delivery Kits
Heron Therapeutics is recalling 1,790 kits of ZYNRELEF (bupivacaine and meloxicam) distributed nationwide because one lot contains an incorrect syringe in the delivery system. No illnesses or injuries have been reported.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III drug recall involving a defective delivery system with no reported illnesses or injuries. The hazard is theoretical—potential improper product delivery—without confirmed patient harm.
Plain-English summary
Heron Therapeutics, Inc. is recalling 1,790 kits of ZYNRELEF (bupivacaine and meloxicam) 400 mg/12 mg due to a defective delivery system. The recall affects Lot #01126739 (expiration 7/31/2023), which was distributed nationwide. One lot of kits contains an incorrect Luer (slip) syringe in the delivery system.
No illnesses or injuries have been reported in connection with this recall. However, the incorrect syringe poses a potential risk related to proper drug delivery and administration.
Healthcare facilities that received kits from the affected lot should stop using them immediately. Patients who received anesthesia administered with ZYNRELEF from this lot should contact their healthcare provider if they have any concerns. Questions can be directed to Heron Therapeutics or the FDA.
The recalled product
- Product
- ZYNRELEF (BUPIVACAINE AND MELOXICAM)
- Brand
- ZYNRELEF
- Manufacturer
- HERON THERAPEUTICS, INC.
- Category
- Drug — Injectable Anesthetic
- Affected units
- 1,790
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 01126739
- Exp 7/31/2023
Distribution
Distributed nationwide across the United States.
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