Browse Drug Recalls
42 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 42 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 42 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 8, 2021 | Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Ocean... | Failed Impurities/Degradation Specifications | Class III | Bausch Health Companies, Inc. |
| Jun 8, 2021 | Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufacture... | Failed Impurities/Degradation Specifications | Class III | Bausch Health Companies, Inc. |
| Jan 7, 2021 | Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured ... | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t... | Class III | Bausch Health Companies, Inc. |
| Jan 7, 2021 | Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceansi... | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t... | Class III | Bausch Health Companies, Inc. |
| Jul 13, 2020 | Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for... | SUBPOTENT DRUG | Class II | Bausch Health Companies, Inc. |
| Jun 17, 2019 | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g bo... | Failed Stability Specifications: Out of specification for viscosity. | Class III | Bausch & Lomb |
| 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 dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| 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 dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| 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 dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| 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 dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| 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 dissolution when measuri... | Class III | Valeant Pharmaceuticals North America LLC |
| 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 their nasal products ... | Class II | Valeant Pharmaceuticals North America LLC |
| 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 their nasal products ... | Class II | Valeant Pharmaceuticals North America LLC |
| 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 their nasal products ... | Class II | Valeant Pharmaceuticals North America LLC |
| Aug 3, 2018 | OCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| 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 without a lot number or e... | Class III | Valeant Pharmaceuticals North America LLC |
| 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 Night Cream is being ... | Class III | Valeant Pharmaceuticals North America LLC |
| Mar 20, 2017 | CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotio... | Discoloration. | Class III | Valeant Pharmaceuticals North America LLC |
| Mar 20, 2017 | CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 ... | Discoloration. | Class III | Valeant Pharmaceuticals North America LLC |
| Jun 10, 2016 | SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, ... | Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphy... | Class III | Valeant Pharmaceuticals North America LLC |
| May 23, 2016 | Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsul... | Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were ... | Class III | Valeant Pharmaceuticals North America LLC |
| 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 | Valeant Pharmaceuticals North America LLC |
| Apr 18, 2015 | Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle,... | Failed Impurities/Degradation Specifications | Class III | Valeant Pharmaceuticals North America LLC |
| Apr 18, 2015 | Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100... | Failed Impurities/Degradation Specifications | Class III | Valeant Pharmaceuticals North America LLC |
| Apr 17, 2015 | Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only.... | Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time po... | Class II | Valeant Pharmaceuticals North America LLC |
| Dec 31, 2014 | Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Ad... | Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 3... | Class II | Valeant Pharmaceuticals North America LLC |
| Oct 2, 2014 | Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufacture... | Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ... | Class III | Valeant Pharmaceuticals International |
| Oct 2, 2014 | Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, M... | Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 ... | Class III | Valeant Pharmaceuticals International |
| Jun 5, 2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count... | Labeling: Incorrect or Missing Package Insert | Class III | Valeant Pharmaceuticals North America LLC |
| Jun 5, 2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-co... | Labeling: Incorrect or Missing Package Insert | Class III | Valeant Pharmaceuticals North America LLC |
| Jun 5, 2014 | APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-co... | Labeling: Incorrect or Missing Package Insert | Class III | Valeant Pharmaceuticals North America LLC |
| May 21, 2014 | Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmac... | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... | Class III | Valeant Pharmaceuticals North America LLC |
| May 21, 2014 | Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-... | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... | Class III | Valeant Pharmaceuticals North America LLC |
| Sep 20, 2013 | Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt... | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an in... | Class III | Valeant Pharmaceuticals North Am |
| Oct 15, 2012 | AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicylic acid... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 ... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 m... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g)... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v)... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... | Class III | Valeant Pharmaceuticals |
| Oct 15, 2012 | AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads pe... | Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic aci... | Class III | Valeant Pharmaceuticals |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.