Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0675-2025·Announced 2025-10-08

Carbamazepine extended release tablets recalled after failing dissolution specifications

American Health Packaging is recalling 360 cartons of Carbamazepine Extended-Release Tablets USP 400 mg from one lot after the product failed dissolution specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 as a specification failure: the record states only that dissolution specifications were not met, without describing a health consequence or reporting injury.

Plain-English summary

Carbamazepine Extended-Release Tablets, USP 400 mg, packaged 30 tablets per carton in three 10-tablet unit dose cards, from American Health Packaging of Columbus, Ohio, are being recalled for failed dissolution specifications.

The recall covers 360 cartons from lot 1024078 with an expiration date of 31 August 2026, carrying carton NDC 60687-594-21 and individual dose NDC 60687-594-11. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.

The enforcement record states the dissolution failure without describing a health consequence, and reports no injuries. Carbamazepine is a prescription medicine, so patients holding the affected lot should contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.

The recalled product

Product: CARBAMAZEPINE (CARBAMAZEPINE)
Brand: CARBAMAZEPINE
Manufacturer: Amerisource Health Services LLC
Category: Drug — Anticonvulsant
Hazard: failed-dissolution
out-of-specification
Affected units: 360

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 (2)

Lot #: 1024078
Exp. Date 08/31/2026

Distribution

Distributed nationwide across the United States.

Same brand · CARBAMAZEPINE

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FDA (Drugs) · 2022-01-19
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Carbamazepine 200mg Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2021-09-29
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Torrent Pharma Recalls Carbamazepine Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2020-06-10
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Taro Pharmaceuticals Recalls Carbamazepine Tablets Sold Without Approval
FDA (Drugs) · 2014-11-05

Same manufacturer · Amerisource Health Services LLC

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