FDA Recall D-0675-2025
Amerisource Health Services LLC · Columbus, OH
Class II Ongoing 241 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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)
Reason for recall
Failed Dissolution Specifications.
Recall record
- Recall number
D-0675-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA.
- Recall initiated
- 2025-09-15
- Classified by FDA Center
- 2025-09-29
- FDA published
- 2025-10-08
- Recalling firm
- Amerisource Health Services LLC
- Firm location
- Columbus, OH
Drug identification
- Brand name(s)
- CARBAMAZEPINE
- Generic name(s)
- CARBAMAZEPINE
- Manufacturer(s)
- American Health Packaging
- NDC(s)
60687-583, 60687-594- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.