FDA Drug recall 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…
- FDA Drug
- Class I
- ongoing
- Published 2024-08-28
On 2024-08-28 the FDA classified a Class I recall of 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… by Hikma Pharmaceuticals Usa, citing 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).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0635-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-07-08 |
| Published | 2024-08-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hikma Pharmaceuticals Usa |
| Distribution | OH, PR |
Product
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
Reason
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)
Identifiers
| ndc | 0143-9386-01 |
|---|---|
| ndc | 0143-9386-10 |
| code_info | Lot #24070381; Exp. 09/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Hikma Pharmaceuticals Usa
- Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manuf…
FDA Drug · Class II · 2026-09-02 · Hikma Pharmaceuticals Usa - Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single Dose Bottles, Distr. by: Hikma Pharmaceuticals USA Inc., Be…
FDA Drug · Class II · 2026-05-06 · Hikma Pharmaceuticals Usa - Lorazepam Injection, USP, 2 mg/mL, 25 x 1mL vials/carton, Rx Only, Manufactured by: Hikma Berkeley Heights, NJ 07922, NDC# 0641-6044-25
FDA Drug · Class II · 2025-08-06 · Hikma Pharmaceuticals Usa - Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, ND…
FDA Drug · Class II · 2024-03-27 · Hikma Pharmaceuticals Usa - 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), Rx only, Manufac…
FDA Drug · Class II · 2023-05-24 · Hikma Pharmaceuticals Usa
All Hikma Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0635-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.