Class II · Moderate risk
R.E.C.K.
Presence of Particulate Matter
Naropin (ropivacaine hydrochloride Injection, USP)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: Hair was found in products
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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 NDCs
63323-0286-05
63323-0286-23
Compare with the code on your package — it is the most precise check available.
Drug: Ropivacaine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Naropin Ropivacaine Hydrochloride NDC 63323-0286 |
5 mg/mL | Injection, Solution Epidural|infiltration|perineural |
Fresenius Kabi USA, LLC | Rx |
- Recalling firm
- Fresenius Kabi USA, LLC
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0727-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Ropivacaine recalls
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Class II · Moderate risk
Fentanyl citrate
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Class I · High risk
Ropivacaine Hydrochloride Injection
Presence of Particulate Matter
Class II · Moderate risk
FentaNYL 500mcg
Lack of Assurance of Sterility
Class II · Moderate risk
fentaNYL Citrate PF 200 mcg/100 mL
Lack of Assurance of Sterility
Other recalls by Fresenius Kabi USA, LLC
All 2026 recalls
Class I · High risk
Tyenne (tocilizumab-aazg)
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Class I · High risk
Morphine Sulfate Injection
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
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