CLASS II Drug recall · Reported 17 Jun 2015 · FDA Enforcement Report

Nifedipine Extended-Release Tablets, USP, 90 mg recalled

Valeant Pharmaceuticals North America is recalling Nifedipine Extended-Release Tablets, USP, 90 mg, distributed nationwide in the US. The recall was initiated on 17 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 1309T27; Expiry: 8/15; Lot #: 1309T28, Expiry: 8/15; Lot #: 1311T33, Expiry: 10/15; Lot #: 1311T34, Expiry: 10/15, Lot #: 1312T40, Expiry: 11/15; Lot #: 1312T41, Expiry: 11/15; Lot #: 1403T23, Expiry: 02/16; Lot #: 1403T21, Expiry: 02/16; Lot #: 1405T21, Expiry: 04/16; Lot #:1405T22, Expiry: 04/16.

Quantity recalled93,237 Bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1116-2015
FDA event ID: 71328
Recalling firm: Valeant Pharmaceuticals North America, Bridgewater, NJ
Classification: Class II
Status: Terminated
Recall initiated: 17 Apr 2015
FDA classified: 8 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

17 Apr 2015	Recall initiated by company
8 Jun 2015	Classified by FDA	+52 days
17 Jun 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

United States Nationwide

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot #: 1309T27; Expiry: 8/15; Lot #: 1309T28, Expiry: 8/15; Lot #: 1311T33, Expiry: 10/15; Lot #: 1311T34, Expiry: 10/15, Lot #: 1312T40, Expiry: 11/15; Lot #: 1312T41, Expiry: 11/15; Lot #: 1403T23, Expiry: 02/16; Lot #: 1403T21, Expiry: 02/16; Lot #: 1405T21, Expiry: 04/16; Lot #:1405T22, Expiry: 04/16.

Where was it sold?

United States Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Valeant Pharmaceuticals North America

All 25

Reported	Class	Recall	Company	Reason	Where
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 300 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Diltiazem HCl CD capsules, 360 mg recalled	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide
20 Feb 2019Drug	CLASS III	Cardizem CD (diltiazem HCl) capsules, 120 mg recalledCardizem Cd	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide

Other Nifedipine recalls

All 10

Reported	Class	Recall	Company	Reason	Where
21 Jul 2021Drug	CLASS II	NIFEdipine Extended-release Tablets, USP 30 mg recalledNifedipine	The Harvard Drug Group	Potency & Assay	NJ, OH
12 Apr 2017Drug	CLASS III	Nifedipine Extended-Release Tablets, 30 mg recalled by Alvogen	Alvogen	Other	Nationwide
12 Apr 2017Drug	CLASS III	Nifedipine Extended-Release Tablets, 60 mg recalled by Alvogen	Alvogen	Other	Nationwide
12 Apr 2017Drug	CLASS III	Nifedipine Extended-Release Tablets, 90 mg recalled by Alvogen	Alvogen	Other	Nationwide
30 Nov 2016Drug	CLASS III	NIFEdipine Capsules USP, 10 mg recalled by Actavis Elizabeth	Actavis Elizabeth	Other	NJ