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Browse Drug Recalls

1,152 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,152 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 1,152 FDA drug recalls in 2021.

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DateProductReasonClassFirm
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 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 MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 1... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
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 Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo... Superpotent and Failed Tablet/Capsule Specifications Class II Aurobindo Pharma USA 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 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 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 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 Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem ... Failed impurities/degradation specifications Class II Ascend Laboratories, 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 Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 ... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Dec 6, 2021 Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), ... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphoteri... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Sing... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Mul... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Dec 6, 2021 LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose C... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injecti... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL)... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free,... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Prese... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial ... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint... MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter... Class II Organics Corporation of America DBA Ambix Labor...
Dec 6, 2021 Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syrin... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for I... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vi... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID),... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Dec 6, 2021 Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL pe... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocor... CGMP Deviations Class II Edge Pharma, 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 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

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.