Browse Drug Recalls

6,274 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,274 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 6,274 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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 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 CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Pro... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 TRP Pink Eye Relief, 10 mL, NDC 17312-013-15 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 CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Steri... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05 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.
Jul 2, 2019 Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manu... 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 CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product S... Lack of Assurance of Sterility Class II Altaire 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 TRP Blur Relief, 15 mL, NDC 17312-002-11 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 Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 P... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, Item#: 4... 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 Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manu... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 TRP Stye Relief, 4 g, NDC 17312-014-13 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 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 OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT... 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 Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-... 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 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% Ophthalmic Demulcent Solution, Net Wt. 0.... 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 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 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 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 Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactur... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solutio... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item#: 258625 P... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 ... 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 OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuS... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, M... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile... 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.

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.