The Recall Desk
ModerateFDA (Drugs)·D-0489-2019·Announced 2019-02-20

Valeant Recalls Cardizem CD Capsules for Dissolution Failures

Valeant Pharmaceuticals is recalling 390 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, potentially affecting drug release.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct safety threat like contamination or mislabeling of a critical allergen.

Plain-English summary

Valeant Pharmaceuticals North America LLC is recalling 390 bottles of Cardizem CD (diltiazem hydrochloride) 240 mg capsules. The affected products are packaged in 30-count and 90-count bottles and were distributed nationwide in the USA and Puerto Rico. The specific lots involved are 18J019P and 18J028P, both with an expiration date of 08/2020.

The recall was initiated because the capsules failed to meet dissolution specifications. This means that high out-of-specification results were found when measuring the amount of drug released at certain time points. This defect may affect the consistency of the medication's performance.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
Brand
CARDIZEM CD
Affected units
390

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lots: a) 18J019P
  • Exp 08/2020
  • b) 18J028P

UPCs (1)

  • 0301870796421

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Valeant Pharmaceuticals North America LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same brand · CARDIZEM CD

Same manufacturer · Valeant Pharmaceuticals North America LLC

See all →