QuVa Pharma Fentanyl Citrate Injection Recall: Lack of Sterility Assurance

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Contact the company & request your remedy

Recalling firmQuVa Pharma, Inc.1075 W Park One Dr Ste 100, N/A · Sugar Land, TX 77478-2576

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✎ GovInfoNow plain-language explainer

What happened, in plain English

QuVa Pharma is recalling certain fentanyl injections that may not be sterile. This could lead to infections if used improperly. The recall affects specific lots with expiration dates up to April 2025.

Why it’s dangerous

The injections lack assurance of sterility, meaning they could contain harmful bacteria or other contaminants. If used, this could cause serious infections or other health complications.

Who’s affected

Healthcare professionals using these injections for epidural procedures are affected. Patients receiving these injections at medical facilities using the recalled lots are at risk.

How to tell if you have this one

Check the product label for the specific lot numbers: 10140284, 10140285, 10140315, 10140316, 10140510, 10140916. The expiration dates range from April 2025 to April 2025.

Brand
QuVa Pharma
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Immediately stop using the recalled fentanyl injections if you have them.

✎ GovInfoNow

Questions people ask

What is the specific product being recalled?

The recalled product is fentanyl citrate injection (200 mcg/100 mL) with 0.125% bupivacaine, compounded for epidural use.

What lots are affected?

Affected lots include 10140284, 10140285, 10140315, 10140316, 10140510, and 10140916.

When do these products expire?

The products expire by April 2025.

Take action

Contact QuVa Pharma

We’ve drafted a message you can send QuVa Pharma to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0296-2025 — QuVa Pharma QuVa Pharma

Hello,

I own a QuVa Pharma that is covered by recall D-0296-2025 from QuVa Pharma.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0296-2025 (March 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0296-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

QuVa Pharma, Inc. recalls 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

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