FDA Drug recall D-0727-2026
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, Fr…
- FDA Drug
- Class II
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class II recall of 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, Fr… by Fresenius Kabi Usa, citing presence of Particulate Matter: Hair was found in products.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0727-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-16 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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
Reason
Presence of Particulate Matter: Hair was found in products
Identifiers
| ndc | 63323-286-01 |
|---|---|
| ndc | 63323-286-20 |
| ndc | 63323-286-05 |
| ndc | 63323-286-23 |
| ndc | 63323-286-09 |
| ndc | 63323-286-31 |
| ndc | 63323-286-11 |
| ndc | 63323-286-35 |
| ndc | 63323-286-03 |
| ndc | 63323-286-00 |
| ndc | 63323-286-33 |
| ndc | 63323-286-63 |
| ndc | 63323-286-30 |
| ndc | 63323-287-01 |
| ndc | 63323-287-20 |
| ndc | 63323-287-03 |
| ndc | 63323-287-21 |
| ndc | 63323-288-01 |
| ndc | 63323-288-10 |
| ndc | 63323-288-06 |
| ndc | 63323-288-20 |
| ndc | 63323-288-03 |
| ndc | 63323-288-11 |
| ndc | 63323-288-07 |
| ndc | 63323-288-21 |
| ndc | 63323-285-01 |
| ndc | 63323-285-10 |
| ndc | 63323-285-06 |
| ndc | 63323-285-20 |
| ndc | 63323-285-03 |
| ndc | 63323-285-13 |
| ndc | 63323-285-07 |
| ndc | 63323-285-23 |
| ndc | 63323-285-57 |
| ndc | 63323-285-64 |
| ndc | 63323-285-51 |
| ndc | 63323-285-65 |
| ndc | 63323-285-02 |
| ndc | 63323-285-61 |
| ndc | 63323-285-04 |
| ndc | 63323-285-63 |
| code_info | Lot #: 6133436, Exp. Date 10/2028 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0727-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.