Naropin — Class II drug recall D-0727-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-07-29, distributed nationwide. Presence of Particulate Matter: Hair was found in products
| Recall number | D-0727-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2026-07-16 |
| Classified | 2026-07-23 |
| Reported by FDA | 2026-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 92,600 vials |
| Reason classes | specification failure |
| NDC | 63323-0285, 63323-0285-01, 63323-0285-02, 63323-0285-03, 63323-0285-04, 63323-0285-06, 63323-0285-07, 63323-0285-10, 63323-0285-13, 63323-0285-20, 63323-0285-23, 63323-0285-51, 63323-0285-57, 63323-0285-61, 63323-0285-63, 63323-0285-64, 63323-0285-65, 63323-0286, 63323-0286-00, 63323-0286-01, 63323-0286-03, 63323-0286-05, 63323-0286-09, 63323-0286-11, 63323-0286-20 and 20 more |
| Lot numbers | 6133436 |
| Expiration dates | 2028-10 |
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 for recall
Presence of Particulate Matter: Hair was found in products
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0727-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.