CLASS II Drug recall · Reported 23 Jul 2014 · FDA Enforcement Report
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/, C-II recalled
Hospira is recalling Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/, C-II, (50 mcg/mL) Single-dose, distributed nationwide in the US. The recall was initiated on 27 Jun 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1433-201
- FDA event ID
- 68751
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Fentanyl Citrate
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jun 2014
- FDA classified
- 14 Jul 2014
- Reported
- 23 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 27 Jun 2014 | Recall initiated by company | |
| 14 Jul 2014 | Classified by FDA | +17 days |
| 23 Jul 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), 50 mL Single-dose Fliptop Vial, Rx only. Hospira, Inc., Lake Forest, IL 60045. NDC: 0409-9094-61.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing.
Which lots are affected?
Lot #: 39474DK, Expiry: 03/01/2016.
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hospira
All 225| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
Other Fentanyl recalls
All 248| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL Citrate, 1,000 mcg recalled by OurPharma | OurPharma | Other | Nationwide |
| Drug | CLASS II | fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg recalled | IntegraDose Compounding Services | Potency & Assay | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution recalled by Wells Pharma of Houston | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, CII recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fentaNYL Citrate Injectable Solution, Narcotic, Cii recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |