Agency classClass IIOur severity:High FDA (Drugs)·D-0297-2025·Announced 2025-04-02

Compounded Fentanyl-Ropivacaine Epidural Injection Recalled Due to Sterility Assurance Concerns

QuVa Pharma is recalling 1,765 cassettes of compounded epidural injection due to lack of sterility assurance. The affected lots were distributed nationwide to institutional and office locations.

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: This is an FDA Class II recall of a high-risk injectable product (epidural injection) due to lack of sterility assurance. The source text does not report any associated illnesses, injuries, or deaths, placing this as a risk-of-harm scenario without reported injury.

Plain-English summary

QuVa Pharma, Inc. is recalling 1,765 cassettes of fentaNYL Citrate PF 200 mcg/100 mL / 0.2% ROPivacaine HCl 200 mg/100 mL in 100 mL NS Yellow CADD FSFF injection for epidural use. This is a compounded product intended for institutional or office use only.

The recall was issued due to lack of assurance of sterility. The affected lots are Lot 10140303 (expiring 04/14/2025), Lots 10140867 and 10140868 (expiring 04/24/2025), and Lot 10140965 (expiring 04/28/2025). These products were distributed nationwide.

Healthcare providers who have received the affected lots should contact QuVa Pharma, Inc. for further instructions regarding the recalled product.

The recalled product

Product: fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 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…
Manufacturer: QuVa Pharma, Inc.
Category: Drug — Injectable / Compounded
Hazard: sterility-assurance
contamination-risk
Affected units: 1,765

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 (8)

Lot
expiry: Lot 10140303
exp 04/14/2025
Lots 10140867
10140868
exp 04/24/2025
Lot 10140965
exp 04/28/2025

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 →

Same manufacturer · QuVa Pharma, Inc.

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Same hazard · sterility assurance