Diltiazem HCl CD capsules — Class III drug recall D-0491-2019
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-0491-2019 |
|---|---|
| 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 | 23,884 bottles |
| Reason classes | specification failure |
| NDC | 68682-0521-01 |
| Lot numbers | 18J035P, 18K093P, 18K094P |
| Expiration dates | 2020-09 |
Product
Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-521-01.
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-0491-2019. 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.