Morphine Sulfate Ampuls Recalled for Expired Filters in Cartons
Hikma Pharmaceuticals is recalling Infumorph 200 (morphine sulfate) ampuls because the sterile filter in the carton has an earlier expiration date than the medication, potentially compromising sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a pain medication for high-risk spinal administration (epidural/intrathecal). The expired filter in the carton may compromise sterility assurance. No reported illnesses or injuries, but the recall addresses a risk-of-harm situation in a critical medication.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling Infumorph 200 (preservative-free morphine sulfate sterile solution) in 20 mL ampuls distributed nationwide. The affected lots are 052001, 052003 (expiring November 2024) and 023012, 023014 (expiring August 2024), totaling 22,644 ampuls.
The filter included in the carton for each ampul has an expiration date that predates the actual medication's expiration date. An expired filter may not maintain its sterility assurance, potentially compromising the integrity of the medication during preparation or administration.
This product is prescribed and administered in hospitals and healthcare facilities for pain management via epidural or intrathecal (spinal) injection.
Healthcare providers and institutions that received affected lots should not use the expired filters with this medication. Hikma Pharmaceuticals recommends contacting the company or the FDA for specific guidance on affected batches.
The recalled product
- Product
- INFUMORPH 200 (MORPHINE SULFATE)
- Brand
- INFUMORPH 200
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Injectable
- Hazard
- filter-defect
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: 052001
- 052003
- Exp. Date 11/2024
- 023012
- 023014
- Exp. Date 08/2024
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- ModerateGas-X Simethicone 125 mg softgels recall for incomplete labeling
FDA (Drugs) · 2026-05-27
- ModerateVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid
FDA (Drugs) · 2026-05-27