Browse Drug Recalls

42 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 42 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 42 FDA drug recalls.

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DateProductReasonClassFirm
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
Jan 26, 2022 Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 5... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lup... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Warfarin Sodium Tablets, USP, 2.5 mg, 100 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 Bumetanide Tablets, USP, 2 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 Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby La... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Heal... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, I... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per carton... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsul... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufact... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healt... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automati... 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.