Fresenius Kabi Recalls Morphine Sulfate Injection USP 2 mg/1 mL over Dilaudid Label Mix-Up
Critical safety alert for clinicians and pharmacies: Fresenius Kabi has initiated a nationwide, voluntary recall of one lot of Morphine Sulfate Injection USP Simplist 2 mg/1 mL pre-filled syringes after discovering they may contain Hydromorphone (Dilaudid) 0.5 mg/0.5 mL syringes packaged under the wrong label. Administration of the wrong opioid strength can trigger life-threatening respiratory depression. Immediately stop using lot 6402820 and quarantine all remaining units for return.
At-a-Glance Recall Facts
- Recalled product: Morphine Sulfate Injection USP, Simplist 2 mg/1 mL, single-dose 1 mL syringe
- NDC (unit-of-use / unit-of-sale): 76045-004-01 / 76045-004-11
- Fresenius Kabi product code: 764411
- Affected lot & expiry: 6402820 | Exp 12/2028
- Distribution dates: 01/27/2023 – 06/08/2023
- Recall depth: User level (hospitals, surgery centers, pharmacies, clinicians)
- Root cause: Carton labeled as Morphine may contain a Hydromorphone syringe
Sources
Clinical Hazard: Why the Mix-Up Matters
Hydromorphone (Dilaudid) is approximately 5–7 times more potent than morphine. If a clinician administers the mislabeled syringe believing it to be morphine, the patient may receive a dangerously high opioid dose, leading to:
- Profound respiratory depression and apnea
- Severe CNS depression, somnolence, or coma
- Cardiac arrest or death, particularly in opioid-naïve, pediatric, geriatric, or respiratory-compromised patients
Required Actions for Health-Care Facilities
- Immediately identify and separate all Morphine Sulfate Injection USP lot 6402820.
- Cease further distribution, dispensing, or administration.
- Contact Inmar Rx Solutions at 1-855-860-7311 (Option 1) to obtain return instructions and, if applicable, a DEA 222 form.
- Notify all clinical staff, satellite pharmacies, and downstream customers of the recall.
- Report any medication errors or patient adverse events to both FDA MedWatch and Fresenius Kabi (see below).
Company & FDA Contacts
Product returns & technical questions: Fresenius Kabi USA Quality Assurance — 1-866-716-2459 (Mon–Fri, 8 a.m.–5 p.m. CST)
Adverse event / quality complaints: 1-800-551-7176 or email productcomplaint.USA@fresenius-kabi.com
FDA MedWatch reporting: fda.gov/medwatch/report.htm
Recall Reference Images
Frequently Asked Questions (FAQ)
1. Why is Fresenius Kabi recalling the Morphine Sulfate Injection Simplist 2 mg/1 mL syringes?
The company identified a carton-level labeling error in which some packages marked as Morphine Sulfate contain a Hydromorphone (Dilaudid) 0.5 mg/0.5 mL syringe. Because hydromorphone is far more potent, accidental administration could cause fatal overdose.
2. Which lot numbers of Fresenius Kabi Morphine Sulfate Injection are involved?
Only lot 6402820 (NDC 76045-004-01 / 76045-004-11) with an expiration date of 12/2028 is affected at this time.
3. What should my facility do with recalled Fresenius Kabi Morphine Sulfate lot 6402820?
Segregate the product immediately, halt use or distribution, and follow the return process through Inmar Rx Solutions at 1-855-860-7311.
4. What patient risks are associated with the mislabeled Morphine Sulfate Injection from Fresenius Kabi?
Because Dilaudid is 5–7 times stronger than morphine, patients may experience respiratory failure, profound sedation, hypotension, or death if the wrong syringe is administered.
5. How do I report an adverse reaction linked to Fresenius Kabi Morphine Sulfate Injection?
Submit a MedWatch report online at fda.gov/medwatch/report.htm or call 1-800-332-1088 for a paper form, and inform Fresenius Kabi Medical Affairs at 1-800-551-7176.
6. Can other lots of Fresenius Kabi Morphine Sulfate Injection be used safely?
Yes. Only lot 6402820 is under recall. Verify lot numbers on all inventory before use, and continue to follow standard medication-safety practices.