Drug & medication recalls Moderate risk

Amerisource Health Services LLC recalls Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Hea…

Recall date
September 15, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0675-2025
FDA classification
Class II
Brand / firm
Amerisource Health Services LLC
Sold / distributed
Nationwide in the USA.

Why it was recalled

Failed Dissolution Specifications.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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)

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