What does it take to recall/withdraw a vaccine/injectable product?

According to the CDC, a vaccine/product is withdrawn or recalled rarely, and it recall has always been due to lack of efficacy or safety of the product in question. The Rotavirus vaccine has been recalled, for example, due to caused intussusception. Gardasil was also recalled, among others.

If you head to CDC website on Vaccine Recalls, you’ll find the following unprompted paragraph under the heading “Why would a vaccine, or certain batches of a vaccine, be withdrawn or recalled?”
https://jessicar.substack.com/p/what-does-it-take-to-recallwithdraw?