Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Altaire Pharmaceuticals, Inc.
Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15
Ophthalmic Drugs·84,216 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Walgreen's Lubricant Eye Ointment, Mineral Oil 42.5%/White Petrolatum 57.3% /Eye Lubricant, Net Wt. 0.125 oz. (3.5g), Distributed by: Wal...
Topical Drugs·45,672 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct., Mfd. By: by Altaire Pharmaceuticals, ...
Topical Drugs·13,375 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15
Ophthalmic Drugs·41,925 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA, ND...
Drugs·105,609 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 15 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue...
Topical Drugs·1,666 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire Pharmaceuticals, Inc. Aque...
Drugs·202,266 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
FreshKote Lubricant Eye Drops, Product Size: 15 mL, NDC 15821-101-15
Ophthalmic Drugs·31,070 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmac...
Topical Drugs·88 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Preservative Free Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item #994881 Product Size: 2 x 10 mL, Distributed by: CVS Pha...
Ophthalmic Drugs·39,744 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT retaine NaCl Ophthalmic Ointment, Product Size: 3.5g, SKU #: 777-3-76
Topical Drugs·19,632 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic Ointment USP, N...
Topical Drugs·87,922 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, Distributed by OCuSOFT, Inc. R...
Topical Drugs·19,632 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Ocusoft Tears Again Lubricant Eye Drops, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-904-15
Ophthalmic Drugs·139,572 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz. (15 mL), Item #317912, Distributed by: CVS Pharmacy ...
Ophthalmic Drugs·464,424 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
iSolutions Nano Tears MO Clear Emollient Lubricant Drops Intensive Sterile, 10 mL, Manufactured by Altaire Pharmaceuticals, Inc. Aquebogu...
Drugs·2,392 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution, USP, 5 %, 5 mL, Sterile, Rx only, Mfd. by: Altaire Pharmaceuticals, In...
Drugs·23,974 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Altaire Sterile Eye Wash, 30 mL (1 fl oz.), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-18
Drugs·414,346 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Ofloxacin Ophthalmic Solution, USP, 0.3%, 5 mL, Rx only, Altaire Pharmaceuticals, Inc., NDC 59390-140-05
Ophthalmic Drugs·102,939 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Altaire Ciprofloxacin Ophthalmic Solution, USP, 0.3%, 10 mL, Rx only, Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-217-10
Ophthalmic Drugs·636 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replenishment Mild Sterile, 0.5 FL OZ (15 mL), Manufactured by: A...
Topical Drugs·4,409 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Preservative Free Lubricant Eye Drops, 60 Sterile Single-Use Containers, 0.02 FL OZ (0.6 mL) EACH, Distributed by: CVS Pharma...
Ophthalmic Drugs·39,072 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Extra Strength Lubricant Gel Drops, Sterile 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, R...
Topical Drugs·159,864 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Natural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL, 25 mL, NDC 68770-130-15
Ophthalmic Drugs·61,830 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #247781, Distributed by: CVS Pharmacy Inc., One CVS Drive, Wo...
Topical Drugs·0 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Dry Eye Relief Lubricant Eye Drops, 0.5 FL OZ (15 mL), Distributed by: CVS Pharmacy, Inc. Woonsocket, RI 0805 Made in the USA ...
Ophthalmic Drugs·39,288 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05
Ophthalmic Drugs·6,024 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY ...
Topical Drugs·48 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 55427, NDC 0574-4025-20
Topical Drugs·195,864 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium 1%, Dry Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Item #799...
Topical Drugs·159,864 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-...
Topical Drugs·441,792 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15
Ophthalmic Drugs·81,217 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops, 15 mL, NDC 68770-104-15
Ophthalmic Drugs·41,906 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment Net Wt. 3.5 g, Rx only, Manufactured for Pe...
Topical Drugs·121,572 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799...
Ophthalmic Drugs·29,326 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Puralube Ointment Petrolatum Ophthalmic Ointment, Sterile Ocular Lubricant, Net Wt. 1 g (NDC 0574-4025-11) and Net Wt. 3.5 g (1/8 oz.) (N...
Topical Drugs·195,864 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, W...
Topical Drugs·0 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.25%/0.5%, 5 mL (Sterile), Rx only, Manufactured by...
Ophthalmic Drugs·532,961 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item#: 258625 Product Size: 0.6 mL x 60 ct, Distributed by: CVS Pharmacy, I...
Ophthalmic Drugs·39,072 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, Twin Pack 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 119...
Topical Drugs·2,870 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO Box 429 Richmond,...
Ophthalmic Drugs·75,996 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceutical...
Drugs·296,314 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Equate Eye Allergy Relief Drops, W-M item #: 567371432 Package Size: 15 mL, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72...
Drugs·2,042,136 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceutical...
Drugs·47 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Clear Eyes Redness Relief, Product Size: 15 mL, UPC#: 6-78112-25415-6
Drugs·0 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25 Single-Use Containers, 0.02 Fl. oz. (0.6 mL), W-M item #: 5...
Ophthalmic Drugs·99,420 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic, 0.6 mL Single Dose (12/CT), Rx only, OCuSOFT, Inc. PO Box 492 Richmond ...
Drugs·9,518 affected·Jul 2, 2019
High RiskFDA
Altaire Pharmaceuticals, Inc.
OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuS...
Ophthalmic Drugs·427,280 affected·Jul 2, 2019