Food, drugs, devices › Hikma Pharmaceuticals USA Inc.

Drug recall: Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Man

FDA enforcement event 94934 · Class I · initiated 8 Jul 2024 · status Ongoing

DrugVoluntary: Firm initiated1 product recordCherry Hill, NJ

Hikma Pharmaceuticals USA Inc. (Cherry Hill, NJ) initiated this drug recall on 8 Jul 2024; FDA lists 1 product record under event 94934, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 13% of the 319 drug enforcement events initiated in 2024 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Hikma Pharmaceuticals USA Inc. has 15 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 Pharmaceuticals USA Inc., Cherry Hill, NJ.

Reason for recall

"Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)"

Distribution

"OH and PR"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0635-2024	Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01	31,400 bags	Class I	Ongoing	28 Aug 2024

Context

13%of 2024 drug events are Class I319 events that year

1product record in this eventfirm median: 1

15events on this register for the firm

Other enforcement events for Hikma Pharmaceuticals USA Inc.

Initiated	Product (first record)	Type	Class	Records
24 Aug 2026	Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bott	Drug	Class II	1
7 Apr 2026	Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceu	Drug	Class II	1
22 Jul 2025	Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, ND	Drug	Class II	1
12 Mar 2024	Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley He	Drug	Class II	1
11 May 2023	Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25	Drug	Class II	1
16 Dec 2022	Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE Gm	Drug	Class II	1
11 Jul 2022	Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724	Drug	Class II	4
5 Aug 2021	Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie G	Drug	Class III	1
7 Dec 2020	Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 0	Drug	Class II	1
3 Nov 2020	Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile dil	Drug	Class II	1

All 15 events for Hikma Pharmaceuticals USA Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)"

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "OH and PR"

Is the recall still ongoing?

FDA lists the status as Ongoing. "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.