The discussions that we have been having this week around test failures and untested medicine lead me to start thinking about failures in the product that are identified. When a defect is identified for released products, the company will need to submit the recall to the FDA. My question is whether a recall would need to be submitted for issues involving missing information or label errors, even if there is no issue with the product itself. If the labels from our simulation were peeling off in the field to the point where there were many customer complaints, would the company want to recall them or just work on improving production methods?

https://www.fda.gov/safety/recalls/industryguidance/ucm129259.htm