Why it was recalled
Presence of Particulate Matter: Hair was found in products
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 6133436, Exp. Date 10/2028
Where it was sold
Nationwide within in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0727-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 16, 2026
- FDA report date
- Jul 29, 2026
- Quantity
- 92,600 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0727-2026, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 99449
- Address
- 3 Corporate Dr
- Code information
- Lot #: 6133436, Exp. Date 10/2028
- Postal code
- 60047-8930
- Report date
- Jul 29, 2026
- Product type
- Drugs
- Recall number
- D-0727-2026
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 92,600 vials
- Reason for recall
- Presence of Particulate Matter: Hair was found in products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within in the USA
- Recall initiation date
- Jul 16, 2026
- Initial firm notification
- Letter
- Center classification date
- Jul 23, 2026