Browse Drug Recalls
6,322 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,322 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 6,322 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Ster... | 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 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 | 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 Preservative Free Lubricant Eye Drops Sensitive Solution, Item#: 4... | 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 | iSolutions Nano Tears MO Clear Emollient Lubricant Drops Intensive Sterile, 1... | 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 Lubricant Eye Drops Multi-Symptom Eye Relief, Item#: 563431, 15 mL... | 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 | Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.... | 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 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 Multi-Action Relief Drops, Item#: 694954, 15 mL, Distributed by: C... | 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 Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distr... | 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 | Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, R... | Lack of Assurance of Sterility | Class II | Altaire Pharmaceuticals, Inc. |
| 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 Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 ... | 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 | 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 | 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 | 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 | CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic So... | 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 | 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 | TRP Blur Relief, 15 mL, NDC 17312-002-11 | 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 Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl... | 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 | Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5... | 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 | 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 | 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 for Mild to Moderate Dry Eye, Sterile, 1 fl. ... | 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 | Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, N... | 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 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 | 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 | 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 | 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 Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Steri... | 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 | Grandall Oftal-Mycin Ophthalmic Ointment, Product Size: 3.5 g | 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.