openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
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drug · product 1 of 1
Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, Pkg by: American Health Packaging, Col. OH 43217, NDC 68084-343-21, blister barcode 6808434311
Labeling or packagingreason.labeling_packaging · v1.0.0
Labeling: Label Mix-Up: A typographical error
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".
