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fda recalls·1d ago·1 min read
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Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes

Aug 4, 2026·read at fda recalls ↗CRLNegative

Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product.

The recall stems from a labeling mistake where the MicroVault container marked as Morphine 2 mg/1 mL may actually hold a prefilled syringe of Dilaudid (hydromorphone) 0.5 mg/0.5 mL.

Because the mix‑up could cause severe respiratory depression or death, especially in opioid‑naïve patients, those with respiratory disease, children, or patients taking CNS depressants are at greatest risk.

No adverse event reports have been received for the affected lot, and the company is recalling the product at the user level to prevent any harm.

source

This writeup was produced by pharmadog from original reporting by fda recalls.

Original headline: “Fresenius Kabi Issues Voluntary Nationwide Recall of One Lot of Morphine Sulfate Injection, USP in a Simplist® Prefilled Syringe Due to Labeling Mix-up”

read at fda recalls ↗
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companies & drugs in this story

companies
FRESENIUS22LEADING2FRESENIUS KABI USAFresenius Kabi USA LLC
drugs
RNS-6022DURAMORPH PF8Infumorph8Kapanol8MORPHINE SULFATE8MS CONTIN8Morphine Sulfate Mallinckrodt8Morphine Sulfate Pfizer8morphine sulfate ER8morphine sulfate SR8
topics
Recall8Pulmonology4Major Depression2Neurology2Oncology2Pain2Psychiatry & CNS2Endocrinology & MetabolismGene Therapy (AAV)HematologyImmunology

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