Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.... | 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 | Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 m... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF Sterile, ... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Clear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6 | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Sing... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic... | 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 | Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, N... | 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 | CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodi... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000, P... | 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 | 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 | Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477, Package ... | 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 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 Preservative Free Lubricant Eye Drops (Carboxymethycellulose Sodiu... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), It... | 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 | 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 | 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 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 | 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. |
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.