FDA Drug recall D-0436-2023
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health P…
- FDA Drug
- Class II
- terminated
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health P… by Amerisource Health Services, citing failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0436-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-01-27 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
Product
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
Reason
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Identifiers
| code_info | Lot 1009065, Exp 12/31/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0436-2023%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.