FDA (Drugs) recall action 72323
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Labeling: Label Error on Declared Strength- Bottles containing 500 mg acetaminophen tablets mislabeled to contain 325 mg tablets.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medline Industries is recalling 325 mg acetaminophen tablets that are actually 500 mg due to a labeling error.
Medline Industries is recalling 500 mg acetaminophen tablets mislabeled as 325 mg. Consumers should stop using the product and return it to the retailer.