Cardizem CD — Class III drug recall D-0488-2019
Terminated recall by Valeant Pharmaceuticals North America LLC, reported 2019-02-20, distributed nationwide. Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount
| Recall number | D-0488-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, United States |
| Recall initiated | 2019-01-30 |
| Classified | 2019-02-14 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2020-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 206 bottles |
| Reason classes | specification failure |
| NDC | 00187-0795, 00187-0795-30, 00187-0795-42, 00187-0795-49, 00187-0796, 00187-0796-30, 00187-0796-42, 00187-0796-49, 00187-0796-50, 00187-0797, 00187-0797-30, 00187-0797-42, 00187-0797-49, 00187-0798, 00187-0798-30, 00187-0798-42, 00187-0799, 00187-0799-42 |
| Expiration dates | 2020-08 |
Product
Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottles (NDC 0187-0796-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.
Reason for recall
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0488-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.