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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Valeant Pharmaceuticals North America LLC: Cardizem CD and Diltiazem HCl CD Capsules Recalled for Failed Dissolution

Agency Publication Date: February 14, 2019
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Summary

Valeant Pharmaceuticals North America LLC is recalling 25,525 bottles of Cardizem CD (diltiazem HCl) and Diltiazem HCl CD extended-release capsules. These blood pressure medications were found to have failed dissolution specifications, meaning they may release the medication into the body faster or slower than intended. Because this could affect how well the medicine works or lead to side effects, consumers should check their bottles for specific lot numbers and expiration dates. If you have the affected medication, contact your healthcare provider or pharmacist for guidance and return the product to the pharmacy.

Risk

The drug failed dissolution testing, resulting in high out-of-specification measurements for the amount of medication released at certain time intervals. If the drug is released too quickly, it could potentially lead to an overdose or increased side effects, while releasing too slowly could make the treatment for blood pressure and chest pain less effective.

What You Should Do

  1. Check your medication bottle for the product name and strength: Cardizem CD (120 mg, 180 mg, 240 mg, 300 mg) or Diltiazem HCl CD (360 mg).
  2. For Cardizem CD 120 mg, look for 30-count (NDC 0187-0795-30) or 90-count (NDC 0187-0795-42) bottles with lots 18J023P or 18J021P and expiration 08/2020.
  3. For Cardizem CD 180 mg, look for 30-count (NDC 0187-0796-30) or 90-count (NDC 0187-0796-42) bottles with lots 18J018P or 18J029P and expiration 08/2020.
  4. For Cardizem CD 240 mg, look for 30-count (NDC 0187-0797-30) or 90-count (NDC 0187-0797-42) bottles with lots 18J019P or 18J028P and expiration 08/2020.
  5. For Cardizem CD 300 mg, look for 30-count (NDC 0187-0798-30) or 90-count (NDC 0187-0798-42) bottles with lots 18J020P or 18J034P and expiration 08/2020.
  6. For Diltiazem HCl CD 360 mg (Oceanside Pharmaceuticals), look for 90-count bottles (NDC 68682-521-01) with lots 18J035P, 18K094P, or 18K093P and expiration 09/2020.
  7. Contact your healthcare provider or pharmacist immediately to discuss a replacement prescription before you stop taking your medication.
  8. Return any unused product to your pharmacy for a refund and contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 for further instructions.
  9. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Consult a medical professional for a replacement medication. Return the affected lots to your place of purchase.

Affected Products

Product: Cardizem CD (diltiazem HCl) capsules, 120 mg (30-count and 90-count)
Model:
NDC 0187-0795-30
NDC 0187-0795-42
Lot Numbers:
18J023P (Exp 08/2020)
18J021P (Exp 08/2020)
Date Ranges: Exp 08/2020
Product: Cardizem CD (diltiazem HCl) capsules, 180 mg (30-count and 90-count)
Model:
NDC 0187-0796-30
NDC 0187-0796-42
Lot Numbers:
18J018P (Exp 08/2020)
18J029P (Exp 08/2020)
Date Ranges: Exp 08/2020
Product: Cardizem CD (diltiazem HCl) capsules, 240 mg (30-count and 90-count)
Model:
NDC 0187-0797-30
NDC 0187-0797-42
Lot Numbers:
18J019P (Exp 08/2020)
18J028P (Exp 08/2020)
Date Ranges: Exp 08/2020
Product: Cardizem CD (diltiazem HCl) capsules, 300 mg (30-count and 90-count)
Model:
NDC 0187-0798-30
NDC 0187-0798-42
Lot Numbers:
18J020P (Exp 08/2020)
18J034P (Exp 08/2020)
Date Ranges: Exp 08/2020
Product: Diltiazem HCl CD capsules, 360 mg (90-count)
Model:
NDC 68682-521-01
Lot Numbers:
18J035P (Exp 09/2020)
18K094P (Exp 09/2020)
18K093P (Exp 09/2020)
Date Ranges: Exp 09/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82021
Status: Resolved
Manufacturer: Valeant Pharmaceuticals North America LLC
Sold By: Pharmacies nationwide
Manufactured In: United States, Canada
Units Affected: 5 products (1023 bottles; 206 bottles; 390 bottles; 22 bottles; 23,884 bottles)
Distributed To: Nationwide
Agency Last Updated: February 22, 2019

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.