Food, drugs, devices › Valeant Pharmaceuticals North America LLC

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

FDA enforcement event 71328 · Class II · initiated 17 Apr 2015 · status Terminated · terminated 12 Apr 2016

DrugVoluntary: Firm initiated1 product recordBridgewater, NJ

Valeant Pharmaceuticals North America LLC (Bridgewater, NJ) initiated this drug recall on 17 Apr 2015; FDA lists 1 product record under event 71328, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 52% of the 292 drug enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 12 Apr 2016. Initiation: voluntary: firm initiated. Valeant Pharmaceuticals North America LLC has 14 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Valeant Pharmaceuticals North America LLC, Bridgewater, NJ.

Reason for recall

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

Distribution

"United States Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1116-2015	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.	93,237 Bottles	Class II	Terminated	17 Jun 2015

Context

52%of 2015 drug events are Class II292 events that year

1product record in this eventfirm median: 1

14events on this register for the firm

Other enforcement events for Valeant Pharmaceuticals North America LLC

Initiated	Product (first record)	Type	Class	Records
30 Jan 2019	Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottle	Drug	Class III	5
24 Aug 2018	Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant	Drug	Class II	3
10 Jul 2018	Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating	Drug	Class III	1
28 Jun 2017	Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA M	Drug	Class III	1
20 Mar 2017	CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America	Drug	Class III	2
10 Jun 2016	SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceut	Drug	Class III	1
23 May 2016	Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valea	Drug	Class III	1
14 Sep 2015	Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic	Device	Class II	1
4 Sep 2015	Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 921	Drug	Class II	1
18 Apr 2015	Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Can	Drug	Class III	2

All 14 events for Valeant Pharmaceuticals North America LLC

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "United States Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 12 Apr 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.