FDA Drug recall D-0128-2023

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per m…

• FDA Drug
• Class II
• terminated
• Published 2023-01-25

On 2023-01-25 the FDA classified a Class II recall of Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per m… by Fresenius Kabi Usa, citing subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Read the official FDA Drug notice

Product

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.

Reason

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Other recalls by Fresenius Kabi Usa

• Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Il…
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• Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fre…
  FDA Drug · Class I · 2026-08-26 · Fresenius Kabi Usa
• Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius K…
  FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
• Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius K…
  FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
• Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi…
  FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa

All Fresenius Kabi Usa recalls

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0128-2023%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.