FDA Drugs recall ·
Carbamazepine Extended-Release Tablets, USP 400 mg… recall
- Recall number
- D-0675-2025
- Date
- (initiated September 15, 2025)
- Company / brand
- Amerisource Health Services LLC
2550 John Glenn Ave Ste A, Columbus, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 360 cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it recalled?
Failed Dissolution Specifications.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 1024078, Exp. Date 08/31/2026
Distribution
Nationwide in the USA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0675-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.