Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), Rx Only, Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7, Canada.

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Recall #: D-0487-2019
Affected scope: 1023 bottles
Initiated: January 30, 2019

Compiled from official public sources by the publisher. · Updated September 2026

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Valeant Pharmaceuticals North America LLC recalled Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0… - a low-severity action.

Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0… was recalled by Valeant Pharmaceuticals North America LLC in February 20, 2019. Reason: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amoun…. Check the official notice for the remedy. Verify recall #D-0487-2019 with the FDA Drug before acting.

The recall

Valeant Pharmaceuticals North America LLC issued this low-severity FDA Drug recall-Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amoun….

Low
severity level: Class III
classification: February 20, 2019
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0487-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottles (NDC 0187-0795-42), 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.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Low (Class III)
Status	Terminated
Recall number	D-0487-2019
Date reported	February 20, 2019
Date initiated	January 30, 2019
Recalling firm	Valeant Pharmaceuticals North America LLC
Firm location	Bridgewater, NJ
Affected scope	1023 bottles
Distribution	Nationwide in the USA and Puerto Rico

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0487-2019) and product description against the item you own. Search the archive
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Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on February 20, 2019. Severity: Low. Recall number: D-0487-2019.

Where was the recalled product distributed? ▼

Distribution: Nationwide in the USA and Puerto Rico.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Similar severity · nearest report date

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Compare this recall with Kian Pee Wan Capsules, 30-count bottles → · All Drugs & Medications recalls

This recall: FDA Drug, reported February 20, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026