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Valeant Pharmaceuticals North America Recalls
25 recalls on record · October 22, 2014 to February 20, 2019 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 20, 2019DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of
Hazard: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
February 20, 2019DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC 0187-0798-30); and b) 90-count bottle
Hazard: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
February 20, 2019DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC 0187-0797-30); and b) 90-count bottle
Hazard: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
February 20, 2019DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC 0187-0796-30); and b) 90-count bottle
Hazard: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
February 20, 2019DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC 0187-0795-30); and b) 90-count bottle
Hazard: Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
October 31, 2018DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant P
Hazard: CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
October 31, 2018DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North
Hazard: CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
October 31, 2018DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant
Hazard: CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
August 15, 2018DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
July 26, 2017DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA M
Hazard: Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
April 26, 2017DrugsFDA
Valeant Pharmaceuticals North America LLC recalls CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL
Hazard: Discoloration.
April 26, 2017DrugsFDA
Valeant Pharmaceuticals North America LLC recalls CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America
Hazard: Discoloration.
July 6, 2016DrugsFDA
Valeant Pharmaceuticals North America LLC recalls SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceut
Hazard: Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
June 22, 2016DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valean
Hazard: Failed Impurities/Degradation Specifications
June 22, 2016DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Can
Hazard: Failed Impurities/Degradation Specifications
June 22, 2016DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valea
Hazard: Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
December 16, 2015Medical DevicesFDA
Valeant Pharmaceuticals North America LLC recalls Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic
Hazard: SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.
November 11, 2015DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 921
Hazard: Failed Dissolution Specifications: Failed 24 month dissolution testing.
June 17, 2015DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA
Hazard: Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
January 28, 2015DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx
Hazard: Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
November 5, 2014DrugsFDA
Valeant Pharmaceuticals North America LLC recalls APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-count HDPE bottle (NDC 0024-5812-07), b) 30-c
Hazard: Labeling: Incorrect or Missing Package Insert
November 5, 2014DrugsFDA
Valeant Pharmaceuticals North America LLC recalls APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-count HDPE bottle (NDC 0024-5811-07), b) 30-c
Hazard: Labeling: Incorrect or Missing Package Insert
November 5, 2014DrugsFDA
Valeant Pharmaceuticals North America LLC recalls APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Vale
Hazard: Labeling: Incorrect or Missing Package Insert
October 22, 2014DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD
Hazard: Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
October 22, 2014DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at V
Hazard: Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset