Infumorph (Hikma) – expired filter (2024)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
Brand
Hikma Pharmaceuticals USA Inc.
Lot Codes / Batch Numbers
Lot #: 052001, 052003, Exp. Date 11/2024, 023012, 023014, Exp. Date 08/2024
Products Sold
Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024
Hikma Pharmaceuticals USA Inc. is recalling Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured due to The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026