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 |
|---|---|---|---|---|
| Dec 31, 2021 | Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Dec 31, 2021 | Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distrib... | Complaint received of foreign matter (metal) embedded in tablet. | Class II | Rubicon Research Private Limited |
| Dec 30, 2021 | Metformin 750 mg Extended Release NDC # 70518-2920-00 | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | RemedyRepack Inc. |
| Dec 29, 2021 | Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, ... | Out-of-specification impurity test result observed at 18-month long term stability time point. | Class III | Lupin Pharmaceuticals Inc. |
| Dec 29, 2021 | Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b... | Failed Impurities/Degradation Specifications | Class II | RemedyRepack Inc. |
| Dec 29, 2021 | Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo... | Superpotent and Failed Tablet/Capsule Specifications | Class II | Aurobindo Pharma USA Inc. |
| Dec 27, 2021 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE ... | CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | VIONA PHARMACEUTICALS INC |
| Dec 27, 2021 | Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bott... | Defective Delivery System | Class II | Padagis US LLC |
| Dec 22, 2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... | Failed Stability Specifications: Out-of-specification results observed in a water loss test that ... | Class III | Lupin Pharmaceuticals Inc. |
| Dec 21, 2021 | Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem ... | Failed impurities/degradation specifications | Class II | Ascend Laboratories, LLC |
| Dec 21, 2021 | Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single... | Lack of Assurance of Sterility | Class II | Ideal Specialty Apothecary, Inc. dba Ideal Phar... |
| Dec 21, 2021 | SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per... | Microbial Contamination of Non-Sterile Product | Class I | Lohxa, LLC |
| Dec 20, 2021 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, R... | Failed Dissolution Specifications | Class II | American Health Packaging |
| Dec 16, 2021 | Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) ... | Subpotent | Class II | Teva Pharmaceuticals USA |
| Dec 15, 2021 | Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro ... | Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria | Class I | Taro Pharmaceuticals U.S.A., Inc. |
| Dec 8, 2021 | Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottl... | Defective Container: The notch in the cap that fits into the nozzle of the dropper could break of... | Class II | Teva Pharmaceuticals USA |
| Dec 7, 2021 | Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distri... | Defective Container: Leaking containers. | Class II | Direct Rx |
| Dec 6, 2021 | kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottl... | Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... | Class I | Valisa MFG LLC |
| Dec 6, 2021 | Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use S... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syrin... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Contain... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dro... | Lack of Assurance of Sterility. | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% /... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preserva... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropp... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Singl... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% ... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single ... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenyl... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmi... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Ph... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syring... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenyleph... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottl... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL pe... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Dexamethasone sodium phosphate, sterile otic solution for injection Preservat... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Prese... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, ... | CGMP Deviations | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / ... | Lack of Assurance of Sterility | Class II | Edge Pharma, LLC |
| Dec 6, 2021 | Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL pe... | CGMP Deviations | Class II | Edge Pharma, 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.