LAKE ZURICH, Ill.--(BUSINESS WIRE)--Aug 4, 2026--
Fresenius Kabi, an operating company of the Fresenius Group, is voluntarily recalling one lot of Morphine Sulfate Injection USP, Simplist ® 2 mg/1 mL due to a label mix-up. The MicroVault labeled as Morphine 2 mg/1 mL, may contain a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. This recall is being conducted to the user level.
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Use of a MicroVault labeled as Morphine Sulfate Injection 2 mg/mL containing a prefilled syringe of Dilaudid (hydromorphone HCl) 0.5 mg/0.5 mL has a reasonable probability of causing serious adverse health consequences, including life-threatening respiratory depression and death. Patients at greatest risk include individuals who do not use opioids on a regular basis, those with underlying respiratory disease, pediatric patients, and those who are also taking central nervous system (CNS) depressants. To date, no adverse event reports have been received for this lot number.
Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, reserve opioid analgesics, including Morphine Sulfate Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Product was distributed nationwide to distributors and wholesalers.
Fresenius Kabi is notifying its distributors and customers and is arranging for return of the recalled product.
If health care facilities have any of the affected lots, they are to immediately discontinue distributing, dispensing, or using the lots and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped or may have been shipped, the product involved in this recall.
Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to Fresenius Kabi Medical Affairs or Vigilance departments at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time, or send an e-mail to either productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
For return kits and 222 forms please contact Inmar Rx Solutions at 1-855-860-7311, from 9 a.m. to 5 p.m. Eastern Standard Time.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Fresenius Kabi
Fresenius Kabi, an operating company of the Fresenius Group, is a global healthcare company providing integrated medicines, technologies, and services for critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, the company’s broad portfolio enables access to high-quality care across emergency medicine, surgery, oncology, intensive care, and at home – reaching 450 million patients each year.
Through complementary business areas, Fresenius Kabi offers highly complex biopharmaceuticals for cancer, autoimmune and endocrine diseases; leading enteral, parenteral and homecare solutions within clinical nutrition; cutting-edge medical technology including infusion pumps, cell and gene therapy devices, disposables, and world-leading blood collection systems; and intravenous generic drugs and fluids that advance essential patient care worldwide. For more information, please visit www.fresenius-kabi.com.
As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.
Correct Product Configuration: Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL lot 6402820
Incorrect Product Configuration: Morphine Sulfate Injection USP, Simplist® 2 mg/1 mL seal with Dilaudid (HYDROmorphone HCl) Injection, USP Simplist® 0.5 mg/0.5 mL syringes (lot 6402813)
Democrats confronted a stark divide between party tradition and a rising tide of progressive energy as voters in Michigan went to the polls on Tuesday.
The primary contest between U.S. Rep. Haley Stevens and insurgent contender Abdul El-Sayed for the party's Senate nomination is testing the swing state electorate's willingness to abandon a time-tested strategy of going with moderate candidates in marquee races.
In a year when Democrats need to rack up as many wins as possible to take back the U.S. Senate, the party has little room for error against the Republican nominee, former U.S. Rep. Mike Rogers.
Republicans faced their own test in Michigan in the governor's race, where President Donald Trump's handpicked candidate, U.S. Rep. John James, defeated Perry Johnson, a wealthy, free-spending outsider.
More primaries were taking place in Kansas, Missouri, Virginia and Washington. The contests will solidify November matchups, particularly in Virginia, where Democrats failed to redraw the state's congressional map earlier this year.
Here are some takeaways from Tuesday's elections:
The choice between El-Sayed and Stevens has become a focal point for Democrats this year, and the race has become bitter. Whoever wins will need to bring splintered factions back into the fold to beat Rogers.
The seat is open because Democratic Sen. Gary Peters is retiring, and Democrats are under pressure to defend it to preserve their chance of winning control of the chamber.
The campaigns have taken sharp aim at one another. Sen. Bernie Sanders, one of El-Sayed’s most prominent supporters, called Stevens “nothing more than an employee” of billionaires. El-Sayed has been a pointed critic of Israel and called the military campaign in Gaza a “genocide,” an accusation rejected by the Israeli and U.S. governments.
Stevens has criticized El-Sayed’s style, comparing him unfavorably to a celebrity who is always “running at the first mic or camera.” She has also suggested he’s not electable in the fall, saying Republicans have been propping him up because they think El-Sayed will be easier to beat.
Republican voters picked their nominee for Michigan governor on Tuesday as well, going with Trump's endorsed candidate, Rep. John James.
The president’s backing typically carries significant weight in Republican politics, but businessman Perry Johnson had lent his campaign more than $30 million, according to Michigan campaign finance records.
Trump's endorsement hasn't always overcome big spending. In Georgia’s race for governor, Rick Jackson spent $100 million, largely of his own money, to defeat Trump-backed Burt Jones in a runoff.
On the Democratic side in Michigan, Secretary of State Jocelyn Benson defeated Genesee County Sheriff Chris Swanson.
The American Israel Public Affairs Committee has long been an influential force in U.S. politics, but it's been under pressure as Democratic support for Israel erodes over the war in Gaza.
The organization has suffered a series of losses in Democratic primaries that saw a surge of progressive candidates. Victors range from Rep. Analilia Mejia, who won a special election to Congress in suburban New Jersey, to Evanston Mayor Daniel Biss, who captured the Democratic nomination for a U.S. House seat in Illinois.
AIPAC's biggest investment has been in Michigan, where it and its affiliates have spent more than $30 million supporting Stevens, a stalwart backer of Israel. El-Sayed and his backers have seized on the group's intervention as an example of the problems of big money in politics.
Although the outcome in Michigan remained uncertain, AIPAC had some success Tuesday. In Missouri, former Rep. Cori Bush fell short in her rematch against Rep. Wesley Bell, who defeated her two years ago.
Bush had blamed her previous loss on AIPAC, even vowing revenge on the organization in her concession speech. "AIPAC, I'm coming to tear your kingdom down!” she pledged.
However, she was quickly defeated as voters in the St. Louis-area district decided to stick with Bell.
One of Democrats' most bitter defeats this cycle took place in Virginia, where that state's supreme court in May overturned a voter-approved initiative to redraw the state's House map to make four more seats easier for the party to win.
The failed effort was part of Democrats' attempt to match Republicans' own redistricting campaign, which was spurred by Trump last year in hopes of making it easier for his party to hold control of the House.
Democrats are optimistic they can recover at least a couple of those Virginia seats the old-fashioned way. On Tuesday, they got what they wanted in the state's two swing seats, with former Rep. Elaine Luria winning the nomination to compete for the 1st District in Virginia Beach and prosecutor Shannon Taylor getting the nod to run in the Richmond-area 2nd District.
The longer shot comes in the heavily rural 5th District in central Virginia, where Tom Perriello, who briefly represented the region in President Barack Obama's first term, won the Democratic nomination to try to win a now even more conservative-leaning seat.
An attendee wears a pin reading "STOP DATA CENTERS" during a primary election night event for Abdul El-Sayed, a progressive candidate in the Democratic primary for U.S. Senate in Michigan, Tuesday, Aug. 4, 2026, at the Majestic Theatre in Detroit. (AP Photo/Julia Demaree Nikhinson)
People prepare to vote at Oakman Elementary School on primary election day, Tuesday, Aug. 4, 2026, in Detroit. (AP Photo/Nic Antaya)
A view of a voting sign at the Portsmouth Township Fire Department, during primary election day, Tuesday, Aug. 4, 2026 in Bay City, Mich. (Kaytie Boomer/The Bay City Times via AP)
