CLASS II Drug recall · Reported 6 Oct 2021 · FDA Enforcement Report
Morphine Sulfate Injection, USP, 2 mg per mL single dose vial recalled
Fresenius Kabi USA is recalling Morphine Sulfate Injection, USP, 2 mg per mL single dose vial, distributed nationwide in the US. The recall was initiated on 17 Sep 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0856-2021
- FDA event ID
- 88698
- Recalling firm
- Fresenius Kabi USA, Melrose Park, IL
- Brand
- Morphine Sulfate
- Manufacturer
- Fresenius Kabi USA, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Sep 2021
- FDA classified
- 27 Sep 2021
- Reported
- 6 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 17 Sep 2021 | Recall initiated by company | |
| 27 Sep 2021 | Classified by FDA | +10 days |
| 6 Oct 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: Cracked vials leading to lack of sterility assurance
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Defective container: Cracked vials leading to lack of sterility assurance
Which lots are affected?
Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Morphine recalls
All 147| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalledMorphine Sulfate | Winder Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets 30 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200 | Hikma Pharmaceuticals USA | Other | Nationwide |