# FDA recall D-0488-2019

> **Valeant Pharmaceuticals North America LLC** · Class III · drug recall initiated 2019-01-30.

## 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.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0488-2019
- **Recalling firm:** Valeant Pharmaceuticals North America LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-01-30
- **Report date:** 2019-02-20
- **Termination date:** 2020-07-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0488-2019

## Citation

> AI Analytics. FDA recall D-0488-2019. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0488-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*