CLASS III Drug recall · Reported 20 Feb 2019 · FDA Enforcement Report
Diltiazem HCl CD capsules, 360 mg recalled
Valeant Pharmaceuticals North America is recalling Diltiazem HCl CD capsules, 360 mg, distributed nationwide in the US. The recall was initiated on 30 Jan 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0491-2019
- FDA event ID
- 82021
- Recalling firm
- Valeant Pharmaceuticals North America, Bridgewater, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Jan 2019
- FDA classified
- 14 Feb 2019
- Reported
- 20 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 30 Jan 2019 | Recall initiated by company | |
| 14 Feb 2019 | Classified by FDA | +15 days |
| 20 Feb 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Which lots are affected?
Lots: 18J035P, 18K094P, 18K093P, Exp 09/2020
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 82021This product is part of a recall event; the main page for the event is Cardizem CD (diltiazem HCl) capsules, 120 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Cardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide | |
| CLASS III | Cardizem CD (diltiazem HCl) capsules, 300 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide | |
| CLASS III | Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide | |
| CLASS III | Cardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
More recalls from Valeant Pharmaceuticals North America
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 300 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS II | Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone) recalled | Valeant Pharmaceuticals North America | Sterility | Nationwide |