A recall of baby wipes sold by Target has been upgraded to the FDA's highest risk level, indicating a risk of serious health effects or death.

Target voluntarily recalled its Up & Up Fragrance Free Baby Wipes and Up & Up Fresh Cucumber Scented Baby Wipes earlier this month after customers complained of product discoloration and reported potential infections associated with use of the baby wipes. 

Subsequent testing by the FDA revealed the presence of Burkholderia cepacia complex and Burkholderia gladioli in product samples, bacteria that can cause life-threatening infections. 

On Monday, the FDA classified the recall as a Class I, indicating 'a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.'

The recall notice stated: 'Use of products contaminated with Burkholderia cepacia complex and Burkholderia gladioli may result in serious and life-threatening infections.

'The products are predominantly used on newborns, infants, and young children, who are particularly vulnerable to opportunistic infection due to their immature immune systems.'  

The recalled wipes were manufactured by a supplier and sold at Target stores nationwide and online at Target.com. 

The recall applies to 6.4 million units of 20-, 72-, 216-, 800- and 1,200-count Up & Up Fragrance Free Baby Wipes sold in plastic pouches and 440,600 units of 72-, 216- and 800-count Up & Up Fresh Cucumber Scented Baby Wipes sold in plastic pouches.

Expiration dates range from May 2028 to November 2028 and a list of UPCs can be found in the original recall notice.  

Burkholderia cepacia complex (Bcc) is a group of bacteria that can cause infections ranging from asymptomatic to serious respiratory infections, especially in people with weak or compromised immune systems. It can also cause a fever and fatigue.

Many Bcc germs are resistant to antibiotics, making them extremely difficult to treat.

The bacteria are commonly found in soil and water and people can become exposed through contaminated surfaces, equipment or person-to-person.

Burkholderia gladioli is a related but distinct species of bacteria that causes similar infections to Bcc. 

In healthy people, using products contaminated with the bacteria on skin with minor lesions will likely result in local infections.

However, 'in immunocompromised individuals, newborns, infants and young children, the infection is more likely to spread into the bloodstream, potentially leading to life-threatening sepsis or pneumonia,' the FDA stated. 

The agency advised customers to immediately stop using the wipes and return them to Target stores for a full refund. 

Target and the baby wipes manufacturer, Sapro Temizlik Urunleri, have received 'a number of consumer complaints and adverse event reports' related to the wipes.

The FDA notice said the reports allege product discoloration and symptoms such as skin irritation, eye irritation and infections 'potentially associated with the use of the product.'

It added: 'These reports remain under investigation. Target is coordinating with the manufacturer and continues to investigate this matter.'

In a statement to Daily Mail, a Target spokesperson said: 'We care deeply about the safety of our guests and our products. Out of an abundance of caution, Target has voluntarily recalled Up&Up Fragrance Free Baby Wipes and Up&Up Fresh Cucumber Baby Wipes. 

'For additional information, including refunds and impacted product information, please view the release.'