pharmadog
News
when
  • Latest
  • Archive
by source
  • All Sources
  • Sources Page
Jobs
department
  • Clinical
  • Regulatory
  • Medical Affairs
  • Commercial
  • R&D / Discovery
  • Biostatistics / Data
  • Manufacturing / CMC
  • Market Access
therapeutic area
  • Oncology
  • Immunology
  • Neuroscience
  • Cardiovascular
  • Metabolic
  • Rare Disease
  • Infectious Disease
location & type
  • Remote Only
  • US Only
  • California
  • Massachusetts
  • Internships
  • Phase 3 Roles
  • All Jobs →
Drugs
by stage
  • Marketed
  • Phase 3
  • Phase 2
  • Phase 1
  • Preclinical
browse
  • Most catalysts
  • Recently active
  • All drugs →
  • Companies
  • Patent cliff
Calendar
what
  • Trial readouts
  • PDUFA dates
  • Approvals
  • Earnings
when
  • Upcoming
  • Month grid
  • Recently passed
Sign InSubscribe
pharmadog

fetch the data · sniff the signal

Discover
  • Jobs
  • News
  • Drugs
  • Calendar
  • Companies
Hubs
  • Topics
  • Patent cliff
  • Publications
  • Readouts
Tools
  • Compare
  • Search
  • Bookmarks
Trust
  • About
  • Sources
  • Contact
Legal
  • Privacy
  • Terms
  • Pricing

© 2026 pharmadog.xyz

made by humans and a good dog

  • home
  • jobs
  • news
  • search
fda medwatch·Aug 5·1 min read
save

Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes

Aug 5, 2026·read at fda medwatch ↗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 medwatch.

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 medwatch ↗
793 words · retrieved Aug 5
sharex / twitterlinkedin

comments(0)

5-min edit window · permanent after that
sign in to leave a comment · permanent archive after 5 minutes
no comments yet — first sniff?

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

related stories

  • Jun 2910 clinical trials to watch in the second half of 2026BioPharma Dive
  • 3d agoSionna says good-bye to 46% of staffers, including execBioSpace
  • May 9The OncFive: Top Oncology Articles for the Week of 5/3onclive
  • Dec 22Fierce Biotech Fundraising Tracker '26: Sling reels in $123M; Circle gathers $92.5MFierce Biotech
  • Aug 11Fresenius Kabi Issues Nationwide Recall of Tyenne® (tocilizumab-aazg) Injection 400 mg/20 mL Vials Due to Presence of Glass Particlesfda medwatch