Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 0409-9094-61 recalled?

Fentanyl Citrate · 25 CARTON in 1 TRAY (0409-9094-61) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE (0409-9094-41)

Yes — this exact package was recalled

2 FDA recalls name the code 0409-9094-61 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Fentanyl Citrate
Strength
FENTANYL CITRATE 50 ug/mL
Form
Injection, Solution · Intramuscular, Intravenous
Labeler
Hospira, Inc.
Type
Human Prescription Drug · DEA CII
Product code
0409-9094

Recalls naming this package

Class II · Moderate risk

Fentanyl Citrate Inj.

Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.

Terminated Packaging defect Pfizer Inc. NDC 00409-9094-12 D-0835-2020

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler