FDA (Drugs) recall action 94492
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.
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
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.
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to foreign material found in reconstituted bottles. This FDA Class II recall affects 17,040 bottles distributed nationwide.
Lupin Pharmaceuticals is recalling Cefdinir Oral Suspension USP 250 mg/5 mL (Lot F305442, expiration 8/30/2025) due to foreign material found in reconstituted bottles. Approximately 17,070 bottles were distributed nationwide.