Infumorph (Preservative-free Morphine Sulfate Sterile Solution) recall
FDA recall D-0392-2024 · initiated Mar 12, 2024
Hikma Pharmaceuticals USA Inc. recalled Infumorph (Preservative-free Morphine Sulfate Sterile Solution) in Mar 2024 — an FDA Class II recall (D-0392-2024) because The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 22,644 ampuls
Details
- Product
- Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
- Recalling company
- Hikma Intl Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Mar 12, 2024
- FDA report date
- Mar 27, 2024
This recall is linked to a product we cover: Duramorph Pf →
Frequently asked
- Was Infumorph (Preservative-free Morphine Sulfate Sterile Solution) recalled?
- Hikma Pharmaceuticals USA Inc. recalled Infumorph (Preservative-free Morphine Sulfate Sterile Solution) in Mar 2024 — an FDA Class II recall (D-0392-2024) because The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Infumorph (Preservative-free Morphine Sulfate Sterile Solution) recalled?
- Per the FDA enforcement record, the reason for recall D-0392-2024 was: The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
- Is a recalled Infumorph (Preservative-free Morphine Sulfate Sterile Solution) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Infumorph (Preservative-free Morphine Sulfate Sterile Solution) are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0392-2024.