CLASS III Drug recall · Reported 20 Feb 2019 · FDA Enforcement Report

Cardizem CD (diltiazem HCl) capsules, 300 mg recalled

Valeant Pharmaceuticals North America is recalling Cardizem CD (diltiazem HCl) capsules, 300 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

Lot, batch or date codesLots: a)18J020P, Exp 08/2020; b) 18J034P, Exp 08/2020

NDC0187-0795, 0187-0796, 0187-0797, 0187-0798, 0187-0799

UPC0301870796421

Quantity recalled22 bottles

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-0490-2019
FDA event ID: 82021
Recalling firm: Valeant Pharmaceuticals North America, Bridgewater, NJ
Brand: Cardizem Cd
Manufacturer: Bausch Health US LLC
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

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.

Where it was distributed

Nationwide in the USA and Puerto Rico

Nationwide 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: a)18J020P, Exp 08/2020; b) 18J034P, Exp 08/2020

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 82021

This 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
20 Feb 2019	CLASS III	Cardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019	CLASS III	Diltiazem HCl CD capsules, 360 mg recalled	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019	CLASS III	Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019	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
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Diltiazem HCl CD capsules, 360 mg recalled	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
31 Oct 2018Drug	CLASS II	Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone) recalled	Valeant Pharmaceuticals North America	Sterility	Nationwide

Other Diltiazem recalls

All 39

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules 12HR recalledDiltiazem Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg recalledDiltiazem Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules recalled	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules recalled	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide