FDA (Drugs) recall action 76539
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Failed dissolution specifications - low dissolution results at S3 stage.
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.
Dr. Reddy's Laboratories is recalling specific lots of Zenatane (isotretinoin) 20 mg capsules because they failed to meet dissolution specifications.
Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) 30 mg capsules because they failed to meet dissolution specifications.
Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because they failed to meet dissolution specifications. The recall covers 4,404 cartons distributed nationwide.
Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because they failed to meet dissolution specifications. The affected lot is distributed nationwide.