FDA Drugs recall ·
Naropin (ropivacaine hydrochloride Injection, USP), 0.5%… recall
- Recall number
- D-0727-2026
- Date
- (initiated July 16, 2026)
- Company / brand
- Fresenius Kabi USA, LLC
3 Corporate Dr, Lake Zurich, IL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 92,600 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Presence of Particulate Matter: Hair was found in products
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 6133436, Exp. Date 10/2028
Distribution
Nationwide within in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0727-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.