FDA Drug recall D-0490-2019
Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30)
- FDA Drug
- Class III
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class III recall of Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30) by Valeant Pharmaceuticals North America, citing failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0490-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-01-30 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Valeant Pharmaceuticals North America |
| Distribution | US |
Product
Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottles (NDC 0187-0798-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
Reason
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Identifiers
| ndc | 0187-0795-30 |
|---|---|
| ndc | 0187-0795-42 |
| ndc | 0187-0795-49 |
| ndc | 0187-0796-30 |
| ndc | 0187-0796-42 |
| ndc | 0187-0796-49 |
| ndc | 0187-0796-50 |
| ndc | 0187-0797-30 |
| ndc | 0187-0797-42 |
| ndc | 0187-0797-49 |
| ndc | 0187-0798-30 |
| ndc | 0187-0798-42 |
| ndc | 0187-0799-42 |
| code_info | Lots: a)18J020P, Exp 08/2020; b) 18J034P, Exp 08/2020 |
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-0490-2019%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.