# FDA recall D-1645-2012

> **American Health Packaging** · Class III · drug recall initiated 2012-07-25.

## Product

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

## 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".

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1645-2012
- **Recalling firm:** American Health Packaging
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-07-25
- **Report date:** 2012-08-22
- **Termination date:** 2013-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1645-2012

## Citation

> AI Analytics. FDA recall D-1645-2012. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1645-2012. Source: US FDA. Licensed CC0.

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