Hikma Acetaminophen Injection Recall: Label Mix-Up Risk
Hikma Pharmaceuticals recalls acetaminophen injection due to label mix-up with dexmedetomidine. This could lead to incorrect medication use. Check your product details and contact Hikma for guidance.
Recall notice
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)
Contact the company
What happened, in plain English
Hikma Pharmaceuticals is recalling acetaminophen injection products because they were mistakenly labeled with dexmedetomidine. This mix-up could cause someone to use the wrong medication, which is dangerous for intravenous use. Read more at govinfonow.com/recall/32592-hikma-acetaminophen-injection-recall-label-mix-up-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32592-hikma-acetaminophen-injection-recall-label-mix-up-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0635-2024
Cite this page
“Hikma Acetaminophen Injection Recall: Label Mix-Up Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32592-hikma-acetaminophen-injection-recall-label-mix-up-risk. Based on FDA recall #D-0635-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0635-2024%22&limit=1).
Why it’s dangerous
The label mix-up means that a bag of dexmedetomidine HCl injection was found inside an overwrap labeled as acetaminophen injection. This could lead to using the wrong medication, which is dangerous for intravenous administration.
Who’s affected
Healthcare professionals who use these injections for medical treatment are most at risk. Patients receiving intravenous acetaminophen under a doctor's prescription may also be affected.
How to tell if you have this one
Check for the product name 'Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL)' on the label. The product was manufactured by Hikma Farmaceutica (Portugal) and distributed by Hikma Pharmaceuticals USA Inc. in the US.
- Brand
Hikma Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Label
Look for the label that says 'Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL)' on the overwrap.
Where it went and when
Where it was distributed
Distributed in Ohio and Puerto Rico.
FDA distribution: “OH and PR” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio, Puerto Rico.
Recall timeline
FDA published this recall 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0635-2024 (July 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0635-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.