FDA (Drugs) recall action 64607
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.
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
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.
Teva Pharmaceuticals is recalling Portia (levonorgestrel and ethinyl estradiol) tablets because they failed appearance specifications.
Teva Pharmaceuticals is recalling specific lots of Jolessa tablets because they failed appearance specifications. The recall is nationwide.