CLASS III Drug recall · Reported 22 Aug 2012 · FDA Enforcement Report
Topiramate Tablets, 50 mg-dose blisters recalled
American Health Packaging is recalling Topiramate Tablets, 50 mg-dose blisters per, distributed nationwide in the US. The recall was initiated on 25 Jul 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1645-2012
- FDA event ID
- 62792
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Jul 2012
- FDA classified
- 14 Aug 2012
- Reported
- 22 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Seizure Medication
Timeline
| 25 Jul 2012 | Recall initiated by company | |
| 14 Aug 2012 | Classified by FDA | +20 days |
| 22 Aug 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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".
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it 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".
Which lots are affected?
Lot #: 113032A, 113032B, Exp 04/13
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from American Health Packaging
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|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | American Health Packaging | Potency & Assay | Nationwide |
Other Topiramate recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Trokendi XR, topiramate extended-release capsules, 25mg recalledTrokendi Xr | Supernus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Eprontia (topiramate) oral solution, 25 mg/mL recalledEprontia | Azurity Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Topiramate Tablets, USP 50 mg recalled by Unichem Pharmaceuticals UsaTopiramate | Unichem Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Trokendi XR (topiramate) extended-release capsules 100 mg recalledTrokendi Xr | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Topiramate Tablets 200 mg recalled by Zydus Pharmaceuticals USATopiramate | Zydus Pharmaceuticals USA | Other | Nationwide |