FDAClass I · Drug · Recall D-0788-2026 · Recalled August 26, 2026
Morphine Sulfate Injection recall — Fresenius Kabi USA, LLC
Agency report date: August 26, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Agency product description and boundaries
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class I: most serious — reasonable probability of serious health consequences or death.
Affected product: Morphine Sulfate Injection recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
More Fresenius Kabi USA recalls
- Tyenne (tocilizumab-aazg) Injection recall — Fresenius Kabi USA, LLCFDA · September 2, 2026
- Ivenix Infusion System (IIS) recall — Fresenius Kabi USA, LLCFDA · June 10, 2026
- LVP software of the Ivenix Infusion System (IIS) recall — Fresenius Kabi USA, LLCFDA · June 10, 2026
Other drug recalls from around the same time
- 0 recall — Baxter Healthcare CorporationFDA · September 9, 2026
- Lactated Ringer's Injection USP recall — B BRAUN MEDICAL INCFDA · September 2, 2026
- Papaverine HCl Injection recall — American Regent, Inc.FDA · August 26, 2026
- Cefazolin in Dextrose recall — Baxter Healthcare CorporationFDA · August 19, 2026
- Optiray Imaging Bulk Package-350 recall — Liebel-Flarsheim Company LLCFDA · August 19, 2026
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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.