Sensorcaine-MPF — Class II drug recall D-0129-2023
Terminated recall by Fresenius Kabi USA, LLC, reported 2023-01-25, distributed nationwide. Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
| Recall number | D-0129-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2022-11-22 |
| Classified | 2023-01-13 |
| Reported by FDA | 2023-01-25 |
| Terminated | 2023-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 31,600 vials |
| Reason classes | potency |
| NDC | 63323-0461, 63323-0461-01, 63323-0461-57, 63323-0463, 63323-0463-01, 63323-0463-57, 63323-0468, 63323-0468-01, 63323-0468-02, 63323-0468-17, 63323-0468-37, 63323-0472, 63323-0472-01, 63323-0472-03, 63323-0472-17, 63323-0472-37 |
| Lot numbers | 6128800 |
| Expiration dates | 2023-12 |
Product
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Reason for recall
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
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-0129-2023. 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.