Reported Jun 17, 2015 · Terminated

Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals…

Valeant Pharmaceuticals North America LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Valeant Pharmaceuticals North America LLC · 400 Somerset Corporate Blvd · Bridgewater, NJ · 08807-2867

Is this the product you have?

  • Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only
  • Manufactured forTeva Pharmaceuticals USA Sailorsville, PA 13960
  • Manufactured in Canada ByValeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada
  • NDC0093-2059-01
Lot codes and dates

10 of 10 products

Products covered by this recall
#Product as published
11309T27
2Expiry: 8/15
3Lot #: 1309T28, Expiry: 8/15
4Lot #: 1311T33, Expiry: 10/15
5Lot #: 1311T34, Expiry: 10/15, Lot #: 1312T40, Expiry: 11/15
6Lot #: 1312T41, Expiry: 11/15
7Lot #: 1403T23, Expiry: 02/16
8Lot #: 1403T21, Expiry: 02/16
9Lot #: 1405T21, Expiry: 04/16
10Lot #:1405T22, Expiry: 04/16.
Amount recalled
93,237 Bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Valeant Pharmaceuticals North America LLC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 12, 2016 · Data as of Sep 19, 6:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.