The Recall Desk
ModerateFDA (Drugs)·D-0842-2023·Announced 2023-06-07

Ropivacaine Hydrochloride Injection Recalled Due to Incomplete Stability Studies

Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP 0.5% nationwide due to incomplete stability studies. The manufacturer ceased operations and could not continue required FDA testing.

What this means for you

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: This is a Class II FDA drug recall without reported illnesses or injuries, and the hazard is theoretical (incomplete stability studies) rather than an identified defect or contamination. The recall is precautionary in nature due to the manufacturer's business closure.

Plain-English summary

Akorn, Inc. is recalling all lots of Ropivacaine Hydrochloride Injection USP, 0.5%, 150 mg/30 mL (5 mg/mL), 30 mL single-dose vials, distributed nationwide in the USA and Puerto Rico.

The recall is due to CGMP deviations: the manufacturer went out of business and could no longer continue the stability studies required by the FDA. These studies are necessary to demonstrate that the drug maintains its safety and effectiveness throughout its shelf life.

The product is a prescription local anesthetic injection. All lots manufactured by Akorn, Inc. are affected. Healthcare providers should contact Akorn regarding inventory management and appropriate disposition of existing stock. Patients should consult their healthcare provider if they have questions about this recall.

The recalled product

Product
Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Single-dose Vial, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injection / Local Anesthetic
Hazard

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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Same hazard · cgmp deviation

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