Valeant Pharmaceuticals North America LLC

Complete recall history across all FDA and CPSC categories — 25 total recalls

Valeant Pharmaceuticals North America LLC appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (24)

FDA drug safety enforcement actions by Valeant Pharmaceuticals North America LLC

Date Product Reason Class
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for diss... Class III
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for diss... Class III
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for diss... Class III
Jan 30, 2019 Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured fo... Failed Dissolution Specifications: high out of specification results for diss... Class III
Jan 30, 2019 Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles... Failed Dissolution Specifications: high out of specification results for diss... Class III
Aug 24, 2018 Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. ... CGMP deviations: Notice received from supplier of a voluntary recall of all t... Class II
Aug 24, 2018 Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Di... CGMP deviations: Notice received from supplier of a voluntary recall of all t... Class II
Aug 24, 2018 Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) ... CGMP deviations: Notice received from supplier of a voluntary recall of all t... Class II
Jul 10, 2018 Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dos... Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed witho... Class III
Jun 28, 2017 Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only,... Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy N... Class III
Mar 20, 2017 CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotio... Discoloration. Class III
Mar 20, 2017 CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 ... Discoloration. Class III
Jun 10, 2016 SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, ... Labeling: Incorrect or Missing Package Insert: Package insert is missing warn... Class III
May 23, 2016 Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsul... Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged i... Class III
Sep 4, 2015 Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distr... Failed Dissolution Specifications: Failed 24 month dissolution testing. Class II
Apr 18, 2015 Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle,... Failed Impurities/Degradation Specifications Class III
Apr 18, 2015 Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100... Failed Impurities/Degradation Specifications Class III
Apr 17, 2015 Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only.... Failed Dissolution Specifications: High out of specification dissolution resu... Class II
Dec 31, 2014 Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Ad... Non-Sterility: Valeant's laboratory observed a positive microbial contaminati... Class II
Jun 5, 2014 APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count... Labeling: Incorrect or Missing Package Insert Class III
Jun 5, 2014 APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-co... Labeling: Incorrect or Missing Package Insert Class III
Jun 5, 2014 APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-co... Labeling: Incorrect or Missing Package Insert Class III
May 21, 2014 Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmac... Labeling: Incorrect or Missing Package Insert: Product is packaged with the i... Class III
May 21, 2014 Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-... Labeling: Incorrect or Missing Package Insert: Product is packaged with the i... Class III

Device Recalls (1)

FDA medical device enforcement actions by Valeant Pharmaceuticals North America LLC

Date Product Reason Class
Sep 14, 2015 Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size A... SPAG-2 6000 Lot J3522070 was released to commerce without being tested for pa... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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