The Recall Desk
HighFDA (Drugs)·D-0295-2025·Announced 2025-04-02

Compounded Fentanyl and Bupivacaine Epidural Injections Recalled for Sterility Assurance

QuVa Pharma recalls compounded fentanyl and bupivacaine epidural injections due to lack of sterility assurance. Affected lots distributed nationwide pose potential infection risks.

What this means for you

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: This is a risk-of-harm product (epidural injection medication) with no reported illnesses or injuries. The FDA Class II classification reflects the serious nature of potential sterility issues, but without reported hospitalizations, it does not meet the Severe threshold. The hazard of non-sterile medication for spinal administration justifies a High rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

QuVa Pharma, Inc. is recalling specific lots of a compounded fentanyl and bupivacaine solution prepared for epidural injection. The FDA is conducting this Class II recall due to lack of assurance of sterility of the compounded medication.

The affected lots are: 10140259, 10140539, 10140687, and 10140688, with expiration date April 2025. The recalled product was distributed nationwide for institutional and office use.

Lack of assured sterility in medications intended for epidural injection—which are administered directly near the spinal cord—represents a potential risk of serious infection. No illnesses or injuries related to this recall have been reported to date.

Patients who received medication from the recalled lots should contact their healthcare provider. Healthcare facilities and offices should immediately stop using any remaining product from these lots.

The recalled product

Product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 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 100, Su
Manufacturer
QuVa Pharma, Inc.
Category
Drug — Compounded Injection
Hazard
  • sterility-assurance-failure
  • infection-risk

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 (5)

  • Lots: 10140259
  • 10140539
  • 10140687
  • 10140688
  • Exp 04/24/2025

Distribution

Distributed nationwide across the United States.

Related recalls

Same category