The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0296-2025·Announced 2025-04-02

Compounded Fentanyl-Bupivacaine Epidural Injections Recalled for Sterility Failure

QuVa Pharma recalls compounded fentanyl-bupivacaine epidural injections due to lack of assurance of sterility. The recall affects 2,310 cassettes distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a compounded injectable medication with sterility assurance failure. No illnesses or hospitalizations are reported in the source. However, the product is used for epidural injections, where contamination poses significant risk of infection. This meets the rubric criterion of a risk-of-harm product where injury has not yet been reported.

Plain-English summary

QuVa Pharma, Inc. is recalling compounded fentanyl citrate 200 mcg/100 mL and bupivacaine HCl 125 mg/100 mL epidural injections distributed nationwide. The recall involves 2,310 cassettes across multiple lot numbers with expiration dates ranging from April 8 to April 24, 2025.

The recall is due to lack of assurance of sterility. Sterile injectable medications must meet strict contamination-free standards. Failure to assure sterility in epidural injections poses a risk of serious infection at the injection site and in surrounding tissues.

This product is intended for institutional and office use only, for epidural pain management. Healthcare providers using affected lots should stop administration immediately and consult with QuVa Pharma and their facility's pharmacy or infection control personnel regarding proper handling of recalled stock.

Patients who received injections from affected lots should contact their healthcare provider if they experience signs of infection, including fever, pain, redness, or swelling at the injection site.

The recalled product

Product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite…
Manufacturer
QuVa Pharma, Inc.
Category
Drug — Epidural Injectable
Hazard
Affected units
2,310

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Lot
  • expiry: Lots 10140284
  • 10140285
  • 10140315
  • 10140316
  • exp 04/08/2025
  • Lot 10140510
  • exp 04/14/2025
  • Lot 10140916
  • exp 04/24/2025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by QuVa Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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