Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection recall
FDA recall D-0480-2024 · initiated Apr 30, 2024
Hikma Injectables USA Inc recalled Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection in Apr 2024 — an FDA Class III recall (D-0480-2024) because Labeling: Wrong Barcode.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Wrong Barcode
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,895 bags
Details
- Product
- Fentanyl 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 company
- Hikma Injectables USA Inc
- Classification
- Class III
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Apr 30, 2024
- FDA report date
- May 8, 2024
Frequently asked
- Was Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection recalled?
- Hikma Injectables USA Inc recalled Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection in Apr 2024 — an FDA Class III recall (D-0480-2024) because Labeling: Wrong Barcode. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0480-2024 was: Labeling: Wrong Barcode
- Is a recalled Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: CH0324001, Exp. Date 3/4/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0480-2024.