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".
Take action
Contact the company
📍Recalling firmAmerican Health Packaging2550 John Glenn Ave Ste A · Columbus, OH 43217-1188
“American Health Packaging Recalls Topiramate Tablets Due to Label Error.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48613-american-health-packaging-recalls-topiramate-tablets-50-mg-30-count. Based on FDA recall #D-1645-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1645-2012%22&limit=1).
American Health Packaging voluntarily recalled Topiramate Tablets, 50 mg, due to a labeling error listing the product as capsules instead of tablets, the FDA said on July 25, 2012. The recall affects 1,170 cartons distributed nationwide.
How to tell if you have it
Brand: American Health Packaging
Product: Topiramate Tablets 50 mg
Configuration: 30-count (3 x 10) unit-dose blisters per carton
NDC: 68084-343-21
UPC: 6808434311
Lot codes: 113032A, 113032B
Expiration date: 04/13
Manufacturer: Cadila Healthcare Ltd.
Distributor: Zydus Pharmaceuticals USA, Inc.
The hazard
The carton label contains a typographical error that incorrectly lists the product configuration as 30 capsules rather than tablets. The FDA classified this labeling mix-up as a Class III recall.
Context
GovInfoNow's records show American Health Packaging has 41 other recalls on record since July 23, 2012. Recent brand recalls include a Buprenorphine Tablets recall for label mix-up hazard on August 19, 2026, and a Nitrofurantoin Capsules recall for dissolution failure risk on May 3, 2022. Other recent recalls of similar products include an American Regent Levocarnitine Injection recall for missing label hazard (April 16, 2026), a Fagron Tropicamide Eye Drops recall due to incorrect formulation (November 20, 2025), and a Haleon Gas-X Simethicone 125mg Softgels recall due to incomplete labeling (May 11, 2026).
How to tell if you have this one
Check your carton for NDC 68084-343-21 and blister barcode 6808434311. Verify the lot numbers are 113032A or 113032B with an expiration date of 04/13. The package contains 30-count (3 x 10) unit-dose blisters.
Brand
American Health Packaging
Product
Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd
Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1645-2012 (July 25, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1645-2012 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.