Browse Drug Recalls
2,138 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,138 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 2,138 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 6, 2019 | Moisturizing Gel Hand Sanitizer (Ethyl Alcohol 62%), 118 mL (4 fl oz) bottles... | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... | Class II | Ecolab Inc |
| Feb 6, 2019 | Express Gel Hand Sanitizer (Ethyl Alcohol 70%), 37 mL (1.25 fl oz) bottles, E... | Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified... | Class II | Ecolab Inc |
| Nov 20, 2018 | Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./... | Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product | Class II | AVKARE Inc. |
| Nov 9, 2018 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Un... | Cross contamination with other products: This sub-recall is being initiated in support of the rec... | Class III | AMERICAN HEALTH PACKAGING |
| Nov 7, 2018 | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60... | Cross contamination with other products: Product is being recalled due to the potential presence ... | Class III | RemedyRepack Inc. |
| Nov 2, 2018 | Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufacture... | Cross Contamination with Other Products | Class II | Sandoz Inc |
| Nov 2, 2018 | Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distribu... | Cross Contamination with Other Products | Class II | Sandoz Inc |
| Nov 2, 2018 | Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactur... | Cross Contamination with Other Products | Class II | Sandoz Inc |
| Nov 2, 2018 | Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactur... | Cross Contamination with Other Products | Class II | Sandoz Inc |
| Nov 2, 2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bo... | Cross Contamination with Other Products | Class III | Sandoz Inc |
| Nov 2, 2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in ... | Cross Contamination with Other Products | Class III | Sandoz Inc |
| Oct 9, 2018 | Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by S... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spr... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Spr... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for S... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spr... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured f... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured f... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for S... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spray... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spr... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spra... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 9, 2018 | AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Sprayology |
| Oct 3, 2018 | Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed... | Microbial Contamination of Non-Sterile Products | Class I | Silver Star Brands |
| Oct 3, 2018 | Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, ... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Silver Star Brands |
| Oct 3, 2018 | Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distribu... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Silver Star Brands |
| Oct 3, 2018 | Native Remedies EyeClear Pro Oral Spray, 2 fl oz (59 mL) per bottle, Distribu... | Microbial Contamination of Non-Sterile Product | Class I | Silver Star Brands |
| Oct 3, 2018 | Native Remedies HypoSlim Oral Spray, 2 fl oz (59 mL) per bottle, Distributed ... | Microbial Contamination of Non-Sterile Products | Class I | Silver Star Brands |
| Oct 3, 2018 | Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed ... | Microbial Contamination of Non-Sterile Products | Class I | Silver Star Brands |
| Sep 17, 2018 | SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g t... | Microbial Contamination of Non-Sterile Product | Class II | Medline Industries Inc |
| Sep 4, 2018 | Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. R... | Cross Contamination With Other Products: | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Aug 31, 2018 | Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) pe... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Beaumont Bio-med, Inc. |
| Aug 31, 2018 | Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Beaumont Bio-med, Inc. |
| Aug 31, 2018 | Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glas... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Beaumont Bio-med, Inc. |
| Aug 31, 2018 | Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Beaumont Bio-med, Inc. |
| Aug 31, 2018 | Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral ... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Beaumont Bio-med, Inc. |
| Aug 31, 2018 | Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Beaumont Bio-med, Inc. |
| Aug 31, 2018 | Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass or... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Beaumont Bio-med, Inc. |
| Aug 31, 2018 | Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per ... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Beaumont Bio-med, Inc. |
| Aug 31, 2018 | NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, package... | CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, ... | Class II | BioLyte Laboratories, LLC |
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.