No, the Moderna COVID-19 vaccine wasn’t recalled in the US

Moderna’s coronavirus vaccine, which is now marketed as Spikevax, was approved by the U.S. Food and Drug Administration (FDA) for adults 18 and older on Jan. 31, 2022, making it the second to receive full FDA approval after Pfizer’s vaccine. 

Now, Moderna’s vaccine has returned to the news cycle, with people sharing information about Moderna potentially issuing a recall of the vaccine. Google Trends data also show that U.S. residents are searching for information about "Moderna vaccine recall."

THE QUESTION

Was the Moderna COVID-19 vaccine recalled in the United States? 

THE SOURCES

• Moderna
• U.S. Food and Drug Administration (FDA) 
• Centers for Disease Control and Prevention (CDC)

THE ANSWER

No, the Moderna COVID-19 vaccine was not recalled in the United States. The drugmaker has recalled some doses of the vaccine in Europe after a “foreign body” was found in one vial. 

WHAT WE FOUND

Moderna announced on April 8 that it would recall one lot of Spikevax produced at ROVI, a manufacturing company in Spain, after a “foreign body” was found in one vial. The impacted vial was “punctured and not administered,” Moderna said in a news release announcing the recall. Moderna did not disclose what was found in the vial. 

The lot consisted of 764,900 doses and was distributed in Norway, Poland, Portugal, Spain and Sweden from Jan. 13-14, 2022, according to Moderna. 

Moderna said no safety concerns have been reported in people who received Spikevax from the recalled lot. Additionally, there are no indications that recalled doses that were already administered are less effective than others, according to Moderna.

The lot is being recalled “out of an abundance of caution,” Moderna said. 

“Moderna does not believe that this poses a risk to other vials in the lot and does not believe that this affects the significant benefit/risk profile of the vaccine,” the news release says. 

The company said it is communicating with health authorities as an investigation moves forward.

A spokesperson for the Food and Drug Administration (FDA) told VERIFY that there is no recall of Moderna’s vaccine in the U.S. The FDA also has lists of recalled vaccines by year on its website, and the two most recent were in 2021 and did not include any of the COVID-19 vaccines. 

The Centers for Disease Control and Prevention says on its website that vaccine recalls are rare and typically done because of concerns about how well the vaccine is working or its safety. 

The CDC says all approved and authorized COVID-19 vaccines are safe and effective, and the agency recommends that those who are eligible get vaccinated as soon as possible if they haven’t already. 

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