Browse Drug Recalls
18,041 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18,041 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 18,041 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 22, 2019 | Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chatt... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Sanofi-Aventis U.S. LLC |
| Oct 22, 2019 | Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Sanofi-Aventis U.S. LLC |
| Oct 22, 2019 | Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Sanofi-Aventis U.S. LLC |
| Oct 22, 2019 | Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219,... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Sanofi-Aventis U.S. LLC |
| Oct 22, 2019 | Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts... | Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Oct 22, 2019 | Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Compan... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Sanofi-Aventis U.S. LLC |
| Oct 22, 2019 | Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Compan... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Sanofi-Aventis U.S. LLC |
| Oct 21, 2019 | PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, ... | Incorrect labeling: Incorrect or missing lot and/or exp date | Class III | Nephron Pharmaceuticals Corporation dba Nephron... |
| Oct 18, 2019 | Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 m... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 18, 2019 | Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. ... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 18, 2019 | Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Dis... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 18, 2019 | Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 ... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 18, 2019 | Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Ph... | Failed Dissolution Specification: Low out of specification dissolution results. | Class II | Mylan Pharmaceuticals Inc. |
| Oct 18, 2019 | Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. ... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 18, 2019 | Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. o... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 18, 2019 | BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle,... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 18, 2019 | Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA ex... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 18, 2019 | BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 75... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 18, 2019 | BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 m... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 18, 2019 | Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg ... | Marketed without an Approved NDA/ANDA | Class II | Basic Reset Inc. |
| Oct 17, 2019 | Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to th... | Labeling: Incorrect or missing package insert. | Class III | Sandoz Inc |
| Oct 17, 2019 | Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx... | Labeling: Incorrect or missing package insert. | Class III | Sandoz Inc |
| Oct 17, 2019 | Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste... | Labeling: Incorrect or missing package insert. | Class III | Sandoz Inc |
| Oct 17, 2019 | AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 4229... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | AVKARE Inc. |
| Oct 17, 2019 | AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 4229... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | AVKARE Inc. |
| Oct 16, 2019 | Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10... | Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. | Class III | Amneal Pharmaceuticals, Inc. |
| Oct 15, 2019 | Viatrexx-Arthros, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Facial, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpo... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio ... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpora... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Inc... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpora... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio I... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Neuro 3, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorp... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporate... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorpor... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 15, 2019 | Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Inc... | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its steri... | Class II | 8046255 Canada Inc. DBA Viatrexx |
| Oct 11, 2019 | Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manuf... | Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached. | Class III | X-Gen Pharmaceuticals Inc. |
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.