Home/Recalls/FDA-D-0727-2026
FDA DrugsClass II

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

Published: July 29, 2026Recall ID: D-0727-2026Category: drugsCountry: US
US
PharmaceuticalFDA DrugsUSUS

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

Recalling Firm: Fresenius Kabi USA, LLC

Reason for Recall / Hazard

Presence of Particulate Matter: Hair was found in products

Product Description & Identification

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

Affected Products

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

Additional Source Details

FieldValue
CityLake Zurich
StateIL
Openfda › Upc › 10363323286033
Openfda › Upc › 20363323285074
Openfda › Upc › 30363323285036
Openfda › Upc › 40363323285579
Openfda › Upc › 50363323287030
Openfda › Upc › 60363323286095
Openfda › Upc › 70363323288075
Openfda › Upc › 80363323286330
Openfda › Upc › 90363323286057
Openfda › Upc › 100363323288037
Openfda › Upc › 110363323286118
Openfda › Upc › 120363323285517
Openfda › UniiV910P86109
Openfda › Route › 1EPIDURAL
Openfda › Route › 2INFILTRATION
Openfda › Rxcui › 1905189
Openfda › Rxcui › 2905191
Openfda › Rxcui › 31734084
Openfda › Rxcui › 41734086
Openfda › Rxcui › 51734090
Openfda › Rxcui › 61734091
Openfda › Rxcui › 71734203
Openfda › Rxcui › 81734204
Openfda › Rxcui › 91734207
Openfda › Rxcui › 101734208
Openfda › Rxcui › 111734347
Openfda › Rxcui › 121734348
Openfda › Rxcui › 131734355
Openfda › Rxcui › 141734356
Openfda › Rxcui › 151734475
Openfda › Rxcui › 161734476
Openfda › Rxcui › 171734479
Openfda › Rxcui › 181734480
Openfda › Rxcui › 191734481
Openfda › Rxcui › 201734482
Openfda › Rxcui › 211734483
Openfda › Rxcui › 221734484
Openfda › Spl idcdcd6c58-85cf-4d7e-9d97-b7c282a4f6b9
Openfda › Brand nameNAROPIN
Openfda › Spl set id23d2d448-a744-4877-9f2d-7e57c198da89
Openfda › Package ndc › 163323-286-01
Openfda › Package ndc › 263323-286-20
Openfda › Package ndc › 363323-286-05
Openfda › Package ndc › 463323-286-23
Openfda › Package ndc › 563323-286-09
Openfda › Package ndc › 663323-286-31
Openfda › Package ndc › 763323-286-11
Openfda › Package ndc › 863323-286-35
Openfda › Package ndc › 963323-286-03
Openfda › Package ndc › 1063323-286-00
Openfda › Package ndc › 1163323-286-33
Openfda › Package ndc › 1263323-286-63
Openfda › Package ndc › 1363323-286-30
Openfda › Package ndc › 1463323-287-01
Openfda › Package ndc › 1563323-287-20
Openfda › Package ndc › 1663323-287-03
Openfda › Package ndc › 1763323-287-21
Openfda › Package ndc › 1863323-288-01
Openfda › Package ndc › 1963323-288-10
Openfda › Package ndc › 2063323-288-06
Openfda › Package ndc › 2163323-288-20
Openfda › Package ndc › 2263323-288-03
Openfda › Package ndc › 2363323-288-11
Openfda › Package ndc › 2463323-288-07
Openfda › Package ndc › 2563323-288-21
Openfda › Package ndc › 2663323-285-01
Openfda › Package ndc › 2763323-285-10
Openfda › Package ndc › 2863323-285-06
Openfda › Package ndc › 2963323-285-20
Openfda › Package ndc › 3063323-285-03
Openfda › Package ndc › 3163323-285-13
Openfda › Package ndc › 3263323-285-07
Openfda › Package ndc › 3363323-285-23
Openfda › Package ndc › 3463323-285-57
Openfda › Package ndc › 3563323-285-64
Openfda › Package ndc › 3663323-285-51
Openfda › Package ndc › 3763323-285-65
Openfda › Package ndc › 3863323-285-02
Openfda › Package ndc › 3963323-285-61
Openfda › Package ndc › 4063323-285-04
Openfda › Package ndc › 4163323-285-63
Openfda › Product ndc › 163323-285
Openfda › Product ndc › 263323-286
Openfda › Product ndc › 363323-287
Openfda › Product ndc › 463323-288
Openfda › Generic nameROPIVACAINE HYDROCHLORIDE
Openfda › Product typeHUMAN PRESCRIPTION DRUG
Openfda › Substance nameROPIVACAINE HYDROCHLORIDE
Openfda › Manufacturer nameFresenius Kabi USA, LLC
Openfda › Application numberNDA020533
Openfda › Is original packagertrue
Event id99449
Address 13 Corporate Dr
Address 2N/A
Code infoLot #: 6133436, Exp. Date 10/2028
Postal code60047-8930
Report date20260729
Product typeDrugs
Product quantity92,600 vials
Reason for recallPresence of Particulate Matter: Hair was found in products
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260716
Initial firm notificationLetter
Center classification date20260723

Check Other Products In Your Household

Free Safety Tools

Safety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:

Barcode ScannerVIN Vehicle CheckPantry Safety Audit

Overview

  • Recalling FirmFresenius Kabi USA, LLC
  • StatusOngoing
  • Risk LevelClass II
  • DistributionNationwide within in the USA
Recall Hazard Severity
High Alert (Class I)
Official Agency Alert

📢 Share Warning

Alert family and friends to keep them safe. Copy this quick alert message:

🚨 SAFETY ALERT: Fresenius Kabi USA, LLC - Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

Check if your household is affected:
https://therecallfile.com/recalls/naropin-ropivacaine-hydrochloride-injection-usp-0-5-100-mg-per-20-ml-5/FDA-D-0727-2026
WhatsAppFacebook

Join Alertlist

Get instant email updates whenever critical safety recalls like this are published.

Featured on Product Hunt

Help support our public safety mission and check out our community launch.

The Recall File - The Google for Product Recalls | Product Hunt

Support The Recall File

Help keep official recall alerts free, accessible, and fast for everyone.

Donate with PayPal

Supports USD, EUR, GBP, International Cards & PayPal

Spread the WordNaropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

Related Recalls

PharmaceuticalUKUK

MHRA Safety Roundup: August 2026

MHRAUK
uk-mhraMedicines Recall

MHRA Safety Roundup: August 2026

Summary of the latest safety advice for medicines and medical device users...

Aug 25, 2026MHRA
PharmaceuticalAustraliaAustralia

CAROTONE skin-brightening products found to contain undeclared prescription-only medicine

TGAAustralia
au-tgaMedicines Safet...

CAROTONE skin-brightening products found to contain undeclared prescription-only medicine

We are advising consumers that CAROTONE products marketed for skin brightening may pose a serious risk to your health and should not be used....

Aug 24, 2026TGA
PharmaceuticalUKUK

Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37

Zentiva Pharma UK LimitedUK
uk-mhraMedicines Recall

Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37

Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles....

Aug 20, 2026Zentiva Pharma UK Limited

Install The Recall File App

Check safety warnings, scan your pantry, and monitor your vehicles directly from your home screen.