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Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

Clear
DateProductReasonClassFirm
Jul 2, 2019 Puralube Petrolatum Ophthalmic Ointment, Net Wt 3.5 gram (1/8 oz), Mfd. for P... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, Rx only 2.5 mL, Altaire... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Item#: 563431, 15 mL... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-77 Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Natural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL, NDC 68770-143-15 Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altaire Sterile Eye Wash, 118 mL (4 fl oz), Altaire Pharmaceuticals, Inc. Aqu... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Walgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodi... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 ActivEyes Altachlore Sodium Chloride Hypertonicity Opthalmic Ointment, 5%, Ma... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distr... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufac... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Ster... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic So... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 TRP/ TARGET up & up intensive relief lubricating eye drop, 10 mL Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Dry Eye Relief Lubricant Eye Drops, 1 FL OZ (30 mL), Distributed b... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manu... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 iSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops St... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15 Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack, Item#: 4953... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservat... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Extra Strength Lubricant Gel Drops Twin Pack, Item#: 258587, Produ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Lubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubri... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025... Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification resu... Class II Lupin Pharmaceuticals Inc.
Jul 2, 2019 Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Pa... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 m... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 m... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, Item#: 63463... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram,... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Steri... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 ActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pha... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointme... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aq... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, R... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jun 28, 2019 Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 ... Presence of Particulate Matter; glass particulates Class I Fresenius Kabi USA, LLC
Jun 26, 2019 PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma ... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...

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.