Stop using now Drug recall · FDA · Published March 22, 2024

IntegraDose Fentanyl Citrate Recall: Leaking Bags Risk Infection

IntegraDose recalls fentanyl citrate injection vials with leaking bags due to lack of sterility. Affected lots from 20231020FEN-1 expire April 2024. Stop using immediately to prevent infection.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0432-2024Drug IntegraDose ›

Stop using this now

Lack of Assurance of Sterility: leaking bags

Take action

Contact the company

Recalling firmIntegraDose Compounding Services LLC719 Kasota Ave Se · Minneapolis, MN 55414-2842

✎ GovInfoNow plain-language explainer

IntegraDose is recalling fentanyl citrate injection vials that may leak, risking infection. This is serious because medical-grade sterile products are critical for safe use and leaks could introduce contaminants. Read more at govinfonow.com/recall/32762-integradose-fentanyl-citrate-recall-leaking-bags-risk-infection.

Source Summary by GovInfoNow · govinfonow.com/recall/32762-integradose-fentanyl-citrate-recall-leaking-bags-risk-infection · Updated August 17, 2026 · FDA enforcement record: FDA #D-0432-2024

Cite this page

“IntegraDose Fentanyl Citrate Recall: Leaking Bags Risk Infection.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32762-integradose-fentanyl-citrate-recall-leaking-bags-risk-infection. Based on FDA recall #D-0432-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0432-2024%22&limit=1).

IntegraDose Compounding Services LLC voluntarily recalled fentaNYL Citrate injection cassettes on March 22, 2024, due to leaking bags that compromise sterility assurance, the FDA said. Owners should contact the company for a refund.

How to tell if you have it

Brand: IntegraDose
Product: fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection
NDC: 71139-6030-1
Lot#: 20231020FEN-1
Expiration: 04/17/2024

The hazard

The recall addresses the lack of assurance of sterility caused by leaking bags. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show IntegraDose Compounding Services LLC has issued six other recalls since September 17, 2021. Recent similar product recalls include an Otsuka ICU Medical 100mL IV Fluid Recall for potential container leaks on October 27, 2025, and a Wells Pharma Fentanyl Citrate Injectable Solution Recall for CGMP deviations on April 1, 2026.

How to tell if you have this one

Check for the lot number 20231020FEN-1 on the vial label. The product expires April 2024. The manufacturer is IntegraDose Compounding Services LLC in Minneapolis, MN.

Brand
IntegraDose
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discard the vial if it leaks or shows signs of contamination.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the U.S” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 19 days after the firm started it.

Mar 22, 2024Firm started the recall
Apr 3, 2024FDA classified it Class II
Apr 10, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/32762-integradose-fentanyl-citrate-recall-leaking-bags-risk-infection">IntegraDose Fentanyl Citrate Recall: Leaking Bags Risk Infection (GovInfoNow)</a>

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-0432-2024 (March 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0432-2024 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.