29-04-2025
Wegovy Recalled as FDA Warns Weight Loss Product 'Inappropriately Released'
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources.
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Novo Nordisk's weight-loss drug Wegovy is the subject of a limited voluntary recall after regulators warned that certain doses were "inappropriately released" following a shipping error.
Why It Matters
Wegovy has become a leading pharmaceutical option in the growing weight-loss drug market, prescribed widely to help individuals with obesity or weight-related medical problems.
Wegovy has seen a significant rise in usage across the United States. A May 2024 Pharmaphorum report noted the drug was getting around 130,000 weekly prescriptions in the U.S., with more than 25,000 people starting on it per week.
A 2024 survey indicated that about one in eight U.S. adults have taken GLP-1 class medications like Wegovy and Ozempic for weight loss and related conditions.
Wegovy is produced by pharmaceutical company Novo Nordisk.
Wegovy is produced by pharmaceutical company Novo Nordisk.
Steve Christo/Corbis via Getty Images
What To Know
Cardinal Health, the distributor responsible for the affected batch, initiated the recall earlier this month, according to federal data.
The U.S. Food and Drug Administration (FDA) classified the recall as a Class II event, indicating that the product could cause temporary or medically reversible health issues, or that the probability of serious adverse health consequences is remote.
The recalled lot, PZFDE06, was set to expire on August 31, 2025, and involved 48 cartons distributed in North Carolina, South Carolina, and Virginia.
Specifically, the 2.4 mg/0.75 mL dose in 4-single-dose prefilled pens was affected, according to the release.
According to a post on the FDA website, the product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution center.
It specified that the product was removed from refrigerated storage for an extended period of time and "inappropriately released."
Proper storage conditions are critical to maintaining the safety effectiveness of semaglutide, Wegovy's active ingredient. Exposure to temperatures outside recommended limits can degrade the drug, potentially reducing its efficacy, according to experts.
Newsweek contacted the recalling firm for comment via email on Tuesday.
What People Are Saying
Alex Miras, professor of endocrinology at Ulster University in Northern Ireland, told Newsweek: "This is a peptide hormone, so its effectiveness may be reduced at higher temperatures."
What Happens Next
At the time of writing, the recall was listed on the FDA's website as ongoing.
Separately, Newsweek reported earlier in April that two Proactiv acne treatment products were voluntarily recalled across the U.S. after tests revealed the presence of benzene, a known human carcinogen. The recall, initiated by Alchemee LLC, affected over 41,000 units of Proactiv Emergency Blemish Relief and Proactiv Skin Smoothing Exfoliator.
