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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Infumorph (Morphine Sulfate) Recalled for Expired Filter Component

Agency Publication Date: March 21, 2024
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Summary

Hikma Pharmaceuticals USA Inc. is recalling 22,644 ampuls of Infumorph (preservative-free morphine sulfate sterile solution), a prescription pain medication. The recall was issued because the filter included in the product carton expires before the actual morphine solution does. Using an expired filter could compromise the quality of the filtration process during administration, although the medication itself remains within its potency and sterility limits.

Risk

An expired filter may fail to properly screen the solution before injection, potentially allowing particulate matter to be administered to the patient. While no injuries have been reported, this defect poses a risk to patient safety during the administration of this sterile injectable medication.

What You Should Do

  1. This recall involves Infumorph (Preservative-free Morphine Sulfate Sterile Solution) in 20 mL ampuls, which are marked with NDC 0641-6039-01.
  2. Identify if you have the affected medication by checking the carton for lot numbers 052001 and 052003 (expiring 11/2024) or lot numbers 023012 and 023014 (expiring 08/2024).
  3. Stop using the recalled product immediately.
  4. If you have health concerns related to the use of this medication, contact your healthcare provider or pharmacist.
  5. Contact Hikma Pharmaceuticals USA Inc. or your distributor to arrange for the return of the affected product lots.
  6. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Infumorph (Preservative-free Morphine Sulfate Sterile Solution) (20 mL ampul)
Variants: Preservative-free, 20 mL ampul
Lot Numbers:
052001 (Exp 11/2024)
052003 (Exp 11/2024)
023012 (Exp 08/2024)
023014 (Exp 08/2024)
NDC:
0641-6039-01

The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94208
Status: Active
Manufacturer: Hikma Pharmaceuticals USA Inc.
Sold By: Hospitals; Wholesalers; Clinical facilities
Manufactured In: United States
Units Affected: 22,644 ampuls
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.