Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Nifedipine Extended-Release Tablets Recalled by Valeant Pharmaceuticals North America LLC Due to Failed Dissolution Specifications: High out of specification dissolution...

Date: April 17, 2015
Company: Valeant Pharmaceuticals North America LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Valeant Pharmaceuticals North America LLC directly.

Affected Products

Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.

Quantity: 93,237 Bottles

Why Was This Recalled?

Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Valeant Pharmaceuticals North America LLC

Valeant Pharmaceuticals North America LLC has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report