Recalls / Class II
Class IID-0675-2025
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 name
- Carbamazepine
- Generic name
- Carbamazepine
- Active ingredient
- Carbamazepine
- Route
- Oral
- NDCs
- 60687-583, 60687-594
- FDA application
- ANDA211623
- Affected lot / code info
- Lot #: 1024078, Exp. Date 08/31/2026
Why it was recalled
Failed Dissolution Specifications.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 360 cartons
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2025-09-15
- FDA classified
- 2025-09-29
- Posted by FDA
- 2025-10-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0675-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.