Food, drugs, devices › Hikma Pharmaceuticals USA Inc.
Drug recall: Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley He
Hikma Pharmaceuticals USA Inc. (Cherry Hill, NJ) initiated this drug recall on 12 Mar 2024; FDA lists 1 product record under event 94208, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 71% 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
"The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot."
Distribution
"Nationwide within the United States"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0392-2024 | Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01 | 22,644 ampuls | Class II | Ongoing | 27 Mar 2024 |
Context
Other enforcement events for Hikma Pharmaceuticals USA Inc.
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: "The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the United States"
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.