US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Sep 15, 2025 (12 months ago)

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

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Dissolution Specifications.

What was recalled

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)

Recalling firm
Amerisource Health Services LLC
NDC code
60687-594-21
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0675-2025

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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