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Browse Drug Recalls

6,228 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,228 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 6,228 FDA drug recalls.

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DateProductReasonClassFirm
Jul 2, 2019 CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: ... 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 Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Oph... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477, Package ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Preservative Free Lubricant Eye Drops Dry Eye Therapy, Twin Pack I... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 m... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL), Dis... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment USP, Ne... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sod... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Preservative Free Lubricant Eye Drops (Carboxymethycellulose Sodiu... 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, 1 fl. ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Ocusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, In... 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 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 iSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops St... 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 CVS Health Multi-Action Relief Drops, Item#: 694954, 15 mL, Distributed by: C... 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 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 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 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 Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, R... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 2.5 mL, Rx only, Manufact... 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 Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, N... 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 Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointme... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodi... 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 Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manuf... 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 iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Fre... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15 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 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 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 Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Dry Eye Relief Lubricant Eye Drops, 0.5 FL OZ (15 mL), Distributed... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. w... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Preservative Free Lubricant Eye Drops, 60 Sterile Single-Use Conta... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Ophthalmic Ointment, 0.5 f... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz.... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product ... 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 iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replen... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.

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.