Fentanyl Injection Bags Recalled Due to Incorrect Barcode Labels
Hikma Injectables USA Inc. has recalled 1,895 bags of Fentanyl 1000mcg/100mL injection (lot CH0324001) due to incorrect barcodes on the product labeling.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall with a labeling error and no reported illnesses, injuries, or product defects. Minor labeling errors are classified as Moderate severity per the FDA rubric.
Plain-English summary
Hikma Injectables USA Inc. is recalling 1,895 bags of Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection that were distributed nationwide. The recalled product has lot number CH0324001 with an expiration date of March 4, 2025. The recall has been initiated due to incorrect barcode labels on the product.
The incorrect barcode may affect proper product identification and inventory tracking in healthcare settings. Healthcare providers and facilities that received this lot should verify they have the affected product and implement appropriate measures to ensure correct product identification.
If you have the recalled product with lot number CH0324001, contact Hikma Injectables USA Inc. Do not use the product until the barcode has been verified or the product has been replaced with a correctly labeled version.
The recalled product
- 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
- Manufacturer
- Hikma Injectables USA Inc
- Category
- Drug — Injectable / Fentanyl
- Hazard
- Affected units
- 1,895
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: CH0324001
- Exp. Date 3/4/2025
Distribution
Distributed nationwide across the United States.
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