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Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards),...

FDA Recall #D-0675-2025 — Class II — September 15, 2025

Recall #D-0675-2025 Date: September 15, 2025 Classification: Class II Status: Ongoing

Product Description

Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; (Individual Dose NDC: 60687-594-11)

Reason for Recall

Failed Dissolution Specifications.

Recalling Firm

Amerisource Health Services LLC — Columbus, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

360 cartons

Distribution

Nationwide in the USA.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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