Topiramate Tablets Recalled for Incorrect Labeling of Product Form
American Health Packaging is recalling Topiramate Tablets due to a labeling error that incorrectly identifies the product as capsules.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the product form (capsules vs. tablets) without reported injuries or illnesses.
Plain-English summary
American Health Packaging is recalling 1,170 cartons of Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters. The product is distributed nationwide under NDC 68084-343-21. The recall is limited to Lot #113032A and 113032B with an expiration date of 04/13.
The recall was initiated due to a typographical error on the carton label. The label incorrectly lists the product configuration as 30 "Capsules" (3 x 10) rather than "Tablets." This is a Class III recall, indicating that the labeling error is unlikely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration date listed above. If the product is found, it should be returned to the distributor or disposed of according to local regulations. No specific instructions for patients currently taking the medication are provided in the source text, but the product form is actually tablets, not capsules.
The recalled product
- 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…
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,170
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 113032A
- 113032B
- Exp 04/13
Distribution
Distributed nationwide across the United States.
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