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 | OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manu... | 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 | iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Fre... | 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 | 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 | CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), ... | 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 | ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50 | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz... | 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 | 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 | 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 | 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 | Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product ... | 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 | 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 | Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 ... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), ... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15 | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF St... | 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 | OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-76 | 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 | OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. w... | 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 Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 ... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | iSolutions Nano Tears MO Clear Emollient Lubricant Drops Intensive Sterile, 1... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Altaire Sterile Eye Wash, 30 mL (1 fl oz.), Altaire Pharmaceuticals, Inc. Aqu... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceutic... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altai... | 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 | 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 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 | Natural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL, 25 mL, NDC 687... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #... | 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 | 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 | ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, M... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 554... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium... | 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 | OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactu... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops, 15 mL, NDC 68770-10... | 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 | 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 | Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, N... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| Jul 2, 2019 | CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size... | 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. |
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.