Agency classClass IIOur severity:High FDA (Drugs)·D-0727-2026·Announced 2026-07-29

Naropin Injection Recall Over Particulate Matter Contamination

Fresenius Kabi is recalling 92,600 vials of NAROPIN (ropivacaine hydrochloride) injection, 0.5%, 10/2028, due to the presence of particulate matter, including hair, found in the product.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a sterile injectable drug with particulate matter contamination, including hair, which poses a risk of harm if administered to patients. No illnesses or injuries have been reported at this time, placing it under the High severity category per the rubric.

Plain-English summary

Fresenius Kabi USA, LLC is recalling NAROPIN (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials. The recall affects 92,600 vials distributed nationwide within the USA.

The recall is being initiated due to the presence of particulate matter, including hair, found in the product. The affected lot is Lot #: 6133436 with an expiration date of 10/2028.

Healthcare professionals and consumers who have been in possession of the affected product should immediately check their inventory and quarantine any affected units. The product should not be used, and distributors should contact Fresenius Kabi to arrange for return or replacement.

For questions, contact Fresenius Kabi USA, LLC. Consumers should contact their healthcare provider if they have any concerns about potential exposure to the recalled product.

The recalled product

Product: NAROPIN (ROPIVACAINE HYDROCHLORIDE)
Brand: NAROPIN
Manufacturer: Fresenius Kabi USA, LLC
Category: Drug — Sterile Injectable
Hazard: particulate-matter
foreign-contamination
Affected units: 92,600

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 #: 6133436
Exp. Date 10/2028

UPCs (12)

0363323286033
0363323285074
0363323285036
0363323285579
0363323287030
0363323286095
0363323288075
0363323286330
0363323286057
0363323288037
0363323286118
0363323285517

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Fresenius Kabi USA, LLC 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 5 products in this recall →

Same manufacturer · Fresenius Kabi USA, LLC

See all →

Severe
Fresenius Kabi Recalls Tyenne Injection Due to Glass Particles
FDA (Drugs) · 2026-09-02
Critical
Fresenius Kabi Recalls Morphine Syringes Due to Labeling Error
FDA (Drugs) · 2026-08-26
High
Xylocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
Moderate
Glycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
High
Lidocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29

Same hazard · particulate matter