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Class III · Lower riskRecall completed

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: CH0324001, Exp. Date 3/4/2025
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Labeling: Wrong Barcode

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forHikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810
NDC63037-100-05
Show the full FDA record
Full product labelFentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
Recalling firmHikma Injectables USA Inc
DistributionNationwide within the United States
Quantity1,895 bags
Recall initiated2024-04-30
Report date2024-05-08
Recall completed—
Recall numberD-0480-2024
ClassificationClass III
FDA statusCompleted
Origin on fileDayton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.