QuVa Pharma Fentanyl Citrate Recall: Lack of Sterility Risk

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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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

QuVa Pharma is recalling specific fentanyl citrate injections due to a lack of assurance of sterility. This could lead to infections if the product is used improperly.

Why it’s dangerous

The product lacks proper sterility assurance, which could lead to infections if the injection is used. This is particularly concerning for epidural procedures where sterile conditions are critical.

Who’s affected

Healthcare professionals using these compounded injections for epidural procedures are most at risk. Patients receiving these injections may also be affected.

How to tell if you have this one

Check for the lot numbers 10140303 (exp 04/14/2025), 10140867/10140868 (exp 04/24/2025), or 10140965 (exp 04/28/2025) on the packaging.

Brand
QuVa Pharma
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers 10140303 (exp 04/14/2025), 10140867/10140868 (exp 04/24/2025), or 10140965 (exp 04/28/2025) on the packaging.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates a lack of assurance of sterility, which could lead to infections. Do not use these products until further notice.

What should I do if I have this product?

Contact QuVa Pharma at 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478 for details on the remedy.

When does this product expire?

The products expire by April 2025 depending on the lot number.

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-0297-2025 — QuVa Pharma QuVa Pharma

Hello,

I own a QuVa Pharma that is covered by recall D-0297-2025 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-0297-2025 (March 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0297-2025 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) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD

Recall notice