FDAHealthSeptember 15, 2025
Amerisource Health Services LLC — 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
⚠️ Failed Dissolution Specifications.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 15, 2025
Nationwide in the USA.
What's affected?
- Product
- 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)
- Brand
- CARBAMAZEPINE
- Lot code
- 1024078
Additional details
Lot #: 1024078, Exp. Date 08/31/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 360 cartons.
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