FDA (Drugs) recall action 90601
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 DISSOLUTION SPECIFICATIONS
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 Lansoprazole 15-mg delayed-release tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting medication effectiveness.
Dr. Reddy's Laboratories is recalling Lansoprazole 35 mg tablets nationwide because they failed dissolution specifications. The tablets may not release the active ingredient properly, reducing medication effectiveness.