Food, drugs, devices › Hikma Injectables USA Inc
Drug recall: Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hik
FDA enforcement event 94528 is a drug recall by Hikma Injectables USA Inc of Dayton, NJ, initiated 30 Apr 2024 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 15% of the 319 drug enforcement events initiated in 2024 carry the same class.
Status: Completed. Initiation: voluntary: firm initiated. Hikma Injectables USA Inc has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Hikma Injectables USA Inc, Dayton, NJ.
Reason for recall
"Labeling: Wrong Barcode"
Distribution
"Nationwide within the United States"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0480-2024 | 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 | 1,895 bags | Class III | Completed | 8 May 2024 |
Context
Other enforcement events for Hikma Injectables USA Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Dec 2024 | ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc | Drug | Class II | 2 |
| 29 Apr 2024 | Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables US | Drug | Class I | 1 |
All 3 events for Hikma Injectables USA Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Labeling: Wrong Barcode"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the United States"
Is the recall still ongoing?
FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.