Hikma recalls Infumorph morphine solution ampules due to expired filter in carton. This could lead to ineffective medication if used after expiration. Check your lot numbers for affected batches.
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
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Contact the company
📍Recalling firmHikma Pharmaceuticals USA Inc.2 Esterbrook Ln · Cherry Hill, NJ 08003-4002
✎ GovInfoNow plain-language explainer
Hikma is recalling Infumorph (preservative-free morphine sulfate) ampules because the filter in the carton expired before the product's expiration date. This means the filter might not work properly, potentially making the medication ineffective if used after the expiration date. Read more at govinfonow.com/recall/32779-hikma-infumorph-morphine-solution-recall-expired-filter-risk.
“Hikma Infumorph Morphine Solution Recall: Expired Filter Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32779-hikma-infumorph-morphine-solution-recall-expired-filter-risk. Based on FDA recall #D-0392-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0392-2024%22&limit=1).
The FDA announced on March 12, 2024, that Hikma Pharmaceuticals USA Inc. is recalling Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampuls, according to the FDA. The hazard involves an expired filter included in the carton prior to the product lot's expiration date.
How to tell if you have it
Brand: Hikma
Product: Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul
NDC: 0641-6039-01
Lot codes: 052001, 052003, 023012, 023014
Expiration dates: 11/2024 and 08/2024
Manufacturer: Hikma Berkeley Heights, NJ 07922
The hazard
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot, according to the FDA.
Context
GovInfoNow's records show Hikma Pharmaceuticals USA INC has 14 other recalls on record since December 17, 2019. Other recent recalls of similar products include Kirkman Lidocaine Cream Recall (February 18, 2026), Safecor Health Fluphenazine Elixir Recall (August 13, 2026), and BD PurPrep Sterile Solution Recall (April 22, 2026).
How to tell if you have this one
Check the lot numbers on the carton: 052001, 052003 (expiring 11/2024) or 023012, 023014 (expiring 08/2024). The product is a 20 mL ampule for prescription use only.
Brand
Hikma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Lot Numbers
Look for lot numbers 052001, 052003 (expiring 11/2024) or 023012, 023014 (expiring 08/2024) on the carton.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 15 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0392-2024 (March 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0392-2024 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.