US Drug Recall Register
Class III · Low risk Terminated Initiated Jul 25, 2012 (14 years ago)

Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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".

What was recalled

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

Recalling firm
American Health Packaging
NDC code
68084-343-21
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1645-2012

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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