If something goes wrong
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A recall is a logistics problem you either prepared for or did not. Everything that makes it survivable is done months earlier, in the batch record.
What makes a recall possible
A code on every bottle that ties back to a batch record, and a record of where that batch went. Without the first you cannot say which bottles. Without the second you cannot reach them.
Producers who batch code but do not record distribution end up recalling everything, because they can identify the affected bottles and not locate them. That is the expensive version.
The first hours
Stop shipping the affected code immediately, before deciding anything else. It is reversible and everything after it is not.
Pull the batch record and read it against the scheduled process. Was the pH within limits, was it measured at the right point, was the fill temperature met. Most scares resolve here, and the record either answers it or it does not.
Keep a retained sample of every batch. A sealed bottle from the batch in question is the difference between testing the actual product and reasoning about it. A few bottles per batch, dated and set aside, costs nothing.
Who to tell
Your state department of agriculture or health, and FDA if the product crossed state lines. There is a reporting obligation when there is reason to believe a product is adulterated or misbranded, and a voluntary early call is treated very differently from a late one.
Then your accounts, directly and in writing, with the code and the action you want them to take. Retailers will pull on your word; they need the code and a date range, not an explanation.
Why records decide the size
A recall is scoped by what you can prove. Good records recall one batch. Poor records recall a season, because you cannot demonstrate which bottles were unaffected.
That is the whole argument for the batch record, and it is worth more than the regulatory obligation that requires it. The record is not paperwork for an inspector. It is the thing that limits the damage on the worst day.