CLASS II Drug recall · Reported 25 Jan 2023 · FDA Enforcement Report
Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalled
Fresenius Kabi USA is recalling Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000, distributed nationwide in the US. The recall was initiated on 22 Nov 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0128-2023
- FDA event ID
- 91198
- Recalling firm
- Fresenius Kabi USA, Lake Zurich, IL
- Brand
- Sensorcaine
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Nov 2022
- FDA classified
- 13 Jan 2023
- Reported
- 25 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 22 Nov 2022 | Recall initiated by company | |
| 13 Jan 2023 | Classified by FDA | +52 days |
| 25 Jan 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Which lots are affected?
Batch #: 6128399, 6128400, 6128401, exp 04/2024
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 91198| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide | |
| CLASS II | Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide |
More recalls from Fresenius Kabi USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Bupivacaine recalls
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recalledBupivacaine Hydrochloride | Huons | Sterility | Nationwide |
| Drug | CLASS II | BUPIVAcaine HCL Sterile injection recalled by Tailstorm Health | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine recalledZynrelef | Heron Therapeutics | Packaging Defects | Nationwide |