FDA Drug recall D-0675-2025
Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Colum…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class II recall of Carbamazepine Extended-Release Tablets, USP 400 mg, 30 Tablets per carton (3x10 unit dose cards), Rx Only, American Health Packaging, Colum… by Amerisource Health Services, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0675-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-15 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
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
Failed Dissolution Specifications.
Identifiers
| ndc | 60687-583-11 |
|---|---|
| ndc | 60687-583-21 |
| ndc | 60687-594-11 |
| ndc | 60687-594-21 |
| code_info | Lot #: 1024078, Exp. Date 08/31/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class III · 2026-05-27 · Amerisource Health Services - Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Col…
FDA Drug · Class III · 2026-05-27 · Amerisource Health Services - Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), R…
FDA Drug · Class II · 2026-04-01 · Amerisource Health Services - Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this…
FDA Drug · Class II · 2026-02-18 · Amerisource Health Services - Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohi…
FDA Drug · Class II · 2025-11-05 · Amerisource Health Services
All Amerisource Health Services recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0675-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.