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Drug FDA Class II Ongoing Failed specifications

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)

Amerisource Health Services LLC Published Oct 8, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Amerisource Health Services LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications.

Hazards

Failed Dissolution · primary

Affected products (1)

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)

CARBAMAZEPINE · 360 cartons

NDC: 60687-583, 60687-594, 60687-583-11, 60687-583-21, 60687-594-11, 60687-594-21
Code info: Lot #: 1024078, Exp. Date 08/31/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Sep 15, 2025
  2. Published
    Oct 8, 2025
Recall number
D-0675-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.