Class II Terminated

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.

Company: Valeant Pharmaceuticals North America Llc
Recall Initiated: April 17, 2015
Posted: June 17, 2015
Recall Number: D-1116-2015
Voluntary / Mandated: Voluntary: Firm initiated
Quantity: 93,237 Bottles
Firm Location: Bridgewater, NJ, United States

Reason for Recall

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

Distribution

United States Nationwide

Lot / Code Info

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.

More recalls by Valeant Pharmaceuticals North America Llc

Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceut...

Feb 20, 2019 · Class III

Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant P...

Oct 31, 2018 · Class II

Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery syst...

Aug 15, 2018 · Class III

Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, In...

Jul 26, 2017 · Class III

CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceut...

Apr 26, 2017 · Class III

View all recalls by this company →

Other recent Class II Drug recalls

Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, L...

Wizcure Pharmaa Private Limited · Mar 4, 2026

Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: Av...

Avkare · Mar 4, 2026

Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufactured Exclusively For: AGEBOX I...

Agebox · Mar 4, 2026

Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPL...

Leo Pharma Inc · Mar 4, 2026

Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per...

Pro Numb Tattoo Numbing Spray Llc · Feb 18, 2026