PharMEDium Fentanyl Citrate 100mL Bag: Expired Diluent Risk
PharMEDium Services recalls 100mL Fentanyl Citrate bags with expired diluent. This may cause ineffective dosing. Contact for replacement.
Lower-risk recall
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Contact the company
What happened, in plain English
PharMEDium Services recalled a specific fentanyl solution product due to expired diluent. Using this product could lead to incorrect dosing if the diluent has expired. Read more at govinfonow.com/recall/41765-pharmedium-fentanyl-citrate-100ml-bag-expired-diluent-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41765-pharmedium-fentanyl-citrate-100ml-bag-expired-diluent-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-1165-2017
Cite this page
“PharMEDium Fentanyl Citrate 100mL Bag: Expired Diluent Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41765-pharmedium-fentanyl-citrate-100ml-bag-expired-diluent-risk. Based on FDA recall #D-1165-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1165-2017%22&limit=1).
Why it’s dangerous
The diluent used to compound the fentanyl solution expired before the product's expiration date. This could lead to ineffective dosing if the solution is used without proper recompounding.
Who’s affected
Healthcare professionals using the recalled fentanyl solution for medical purposes. Patients receiving this treatment are at risk if the solution is used incorrectly.
How to tell if you have this one
Check for the 100mL LifeCare Bag with NDC 61553-112-52. Lots 170850012C and 170850020C expired June 25, 2017.
- Brand
PharMEDium Services- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1165-2017 | Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52.; Lots: 170850012C and 170850020C Exp. 06/25/17 | 590 bags |
| D-1166-2017 | Fentanyl Citrate (Preservative Free) 20 mcg per mL (2,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-605-52; Lot: 170850021C Exp. 06/25/17 | 295 bags |
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the bag to confirm if it's in the recalled batch.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1165-2017 (April 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1165-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.