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Morphine Sulfate Injection 2 mg/mL Prefilled Syringes
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DRUG RECALLCRITICAL

Morphine Sulfate Injection 2 mg/mL Prefilled Syringes

Fresenius Kabi recalls Morphine Sulfate 2 mg/mL syringes over a label mixup that may contain Dilaudid.

What to do

Consumers and healthcare providers should immediately stop using the recalled syringes, quarantine them, and contact Fresenius Kabi for return and replacement instructions.

Recalled
Listed
Updated
Recall No.
D-0788-2026
Agency
FDA
Firm
Fresenius Kabi USA, LLC
Recall ID
99533
Status
ONGOING

Recall at a glance

Quantity recalled
625500 syringes

Why it was recalled

Fresenius Kabi is recalling Morphine Sulfate Injection, USP, 2 mg/1 mL, 1 mL single-dose Simplist prefilled syringes because a syringe labeled as Morphine may actually contain Dilaudid 0.5 mg/0.5 mL. This label mixup poses a serious risk of opioid overdose or underdose for patients.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Tyenne® (tocilizumab-aazg) Injection, 400 mg 20 mL (20mg mL) 20 mL vial

Lot code
16UI07
Best-by
08/2028
NDC
65219-594-20
First Ship Date
03 03 2026
Last Ship Date
03 25 2026

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-08-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification