Browse Drug Recalls

278 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 278 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 278 FDA drug recalls.

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DateProductReasonClassFirm
Sep 2, 2025 Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Ta... Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product pack... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Aug 5, 2025 Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled ... Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, cont... Class II Cardinal Health Inc.
Jul 30, 2025 Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech... CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... Class II Cardinal Health Inc.
Jul 30, 2025 Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South ... CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... Class II Cardinal Health Inc.
Jul 30, 2025 RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Take... CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... Class II Cardinal Health Inc.
Jun 19, 2025 Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packag... Defective container; blister packaging inadequately sealed. Class II The Harvard Drug Group LLC
Apr 9, 2025 Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens ... Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products... Class II Cardinal Health Inc.
Nov 13, 2023 Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glyco... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packag... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged ... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... Non-Sterility Class I Kilitch Healthcare India Limited
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 F... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL)... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (1... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bot... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, ... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Jun 13, 2023 Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL O... CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l... Class II K.C. Pharmaceuticals, Inc
Jul 15, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 ... CGMP Deviations Class II Vi-Jon, LLC
Jul 15, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 F... CGMP Deviations; Class II Vi-Jon, LLC
Jul 15, 2022 Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 F... CGMP Deviations Class II Vi-Jon, LLC
Apr 5, 2022 Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pe... TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... Class II Cardinal Health Inc.
Apr 5, 2022 Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Pr... TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... Class I Cardinal Health Inc.
Apr 5, 2022 Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose P... TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage ... Class II Cardinal Health Inc.
Jan 26, 2022 ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered In... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 FOLIC ACID TABLETS, USP, 1MG, 100 Tablets per bottle, Rx Only, Manufactured b... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuati... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 CHLORTHALIDONE Tablets, USP, 25MG, 1000 Tablets, Rx only, Manufactured by: A... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactu... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg pe... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Ma... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), M... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufa... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Ma... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx O... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amnea... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%,... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx onl... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Man... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bott... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applic... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tab... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE

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.