The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

10626–10650 of 29158

  • SevereFDA (Drugs)·D-0357-2020·2019-11-27

    Altaire Recalls Perrigo Sulfacetamide Sodium Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Perrigo Sulfacetamide Sodium Ophthalmic Ointment because the product lacks assurance of sterility.

    Product
    Perrigo Sulfacetamide Sodium Ophthalmic Ointment USP, 10% Sterile, Rx only, Net Wt 3.5 g, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4190-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0404-2020·2019-11-27

    CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling CVS Health Lubricant Eye Drops Advanced Relief due to a lack of assurance of sterility. Consumers should stop using the product and contact CVS Pharmacy for a refund.

    Product
    CVS Health Lubricant Eye Drops Advanced Relief, Item#: 563419, Product Size: 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0414-2020·2019-11-27

    Altaire Eye Ointment Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling iSolutions ActivEyes Nighttime Lubricant Eye Ointment due to a lack of assurance of sterility.

    Product
    iSolutions ActivEyes Nighttime Lubricant Eye Ointment Preservative Free, Sterile, Net Wt: 3.5 g (1.8 oz), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-190-50
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0485-2020·2019-11-27

    Altaire Recalls Oftal-Mycin Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Grandall Colirio Oftal-Mycin Redness Relief Eye Drops because the product may lack assurance of sterility.

    Product
    Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, Product Size: 15mL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0415-2020·2019-11-27

    Altaire Recalls Altacaine Ophthalmic Solution Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Altacaine ophthalmic solution because the company cannot ensure the product is sterile.

    Product
    Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC 59390-181-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0442-2020·2019-11-27

    Altaire Recalls OCuSOFT Goniosoft Ophthalmic Solution for Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Solution due to a lack of assurance of sterility.

    Product
    OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, Net Wt. 0.5 fl oz (15 mL), Mfd. for: OCuSOFT Inc. PO Box 429 Richmond, TX 77406-0429, NDC 54799-503-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0163-2020·2019-11-27

    Mical Seafood Recalls Tuna Saku Due to Scombroid Poisoning Complaints

    Mical Seafood is recalling specific lots of Tuna Saku products due to customer complaints of scombroid food poisoning. The recall covers products with production dates from April to May 2019.

    Product
    Tuna Saku AAA 8-12oz 10lb case Tuna Saku AAA 12-14oz 10lb case Tuna Saku AAA 16-20oz 10lb case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0372-2020·2019-11-27

    Equate Support Harmony Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Support Harmony Lubricant Eye Drops due to a lack of assurance of sterility. The recall covers 17,613 units distributed nationwide.

    Product
    Equate Support Harmony Lubricant Eye Drops, Restores Tears, 0.33 Fl. oz. (10 mL), Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-145-10 (Note: Support Harmony packaging was discontinued in January 2018.)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0397-2020·2019-11-27

    Altaire Recalls Ocusoft Goniosoft Ophthalmic Solution Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Ocusoft Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution due to a lack of assurance of sterility.

    Product
    Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution, 15 mL, Manufactured for: Ocusoft, Inc., Richmond, TX 77406-0429, NDC 54799-503-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0463-2020·2019-11-27

    Altaire Recalls Women's Tear Stimulation Dry Eye Drops for Sterility Concerns

    Altaire Pharmaceuticals is recalling Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops due to a lack of assurance of sterility.

    Product
    Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-103-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0401-2020·2019-11-27

    CVS Health Lubricating Gel Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Lubricating Gel Drops due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0391-2020·2019-11-27

    CVS Health Preservative Free Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the pharmacy.

    Product
    CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5% Glycerin 1% Polysorbate 80 0.5%), Advanced Relief, 30 Sterile Single-Use Containers 0.02 fl. oz. (0.6 mL) each, Item #563442, NDC 50428 30295 8, Distributed by: CVS Pharmacy Inc., One CVS Drive,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2020·2019-11-27

    Altaire Recalls OCuSOFT Eye Wash Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Eye Wash Sterile Isotonic because the product may not be sterile. Consumers should stop using the product and contact the manufacturer.

    Product
    OCuSOFT Eye Wash Sterile Isotonic, 4 FL OZ (118 mL), Manufactured for OCuSOFT, INC Richmond, TX 7406-0429 Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 Made in USA, NDC 54799-565-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0162-2020·2019-11-27

    Mical Seafood Recalls Tuna Steaks Due to Scombroid Poisoning Complaints

    Mical Seafood is recalling specific lots of tuna steaks after customer complaints of scombroid food poisoning. The recall covers products with production dates from April to May 2019.

    Product
    Tuna Steaks 4oz, 6oz, 8oz, 10oz AA 10lb case Tuna Steaks 4oz, 6oz, 8oz, 10oz AAA 10lb case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0427-2020·2019-11-27

    Altaire NanoTears Lubricant Gel Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling 137 units of iSolutions NanoTears HA Preservative Free Multi-Dose Lubricant Gel Drops due to a lack of assurance of sterility.

    Product
    iSolutions NanoTears HA Preservative Free Multi - Dose Lubricant Gel Drops Sterile, 0.33 FL OZ (10 mL), Manufactured by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-208-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0379-2020·2019-11-27

    CVS Health Preservative Free Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility. The recall covers 114,504 units distributed nationwide.

    Product
    CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #994883, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0437-2020·2019-11-27

    Altaire ActivEyes Lubricant Gel Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops due to a lack of assurance of sterility. The recall affects 88 units distributed nationwide.

    Product
    ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF Sterile, 0.25 FL OZ (7.5 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-148-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0434-2020·2019-11-27

    Altaire Pharmaceuticals Recalls iSolutions Nano Tears Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops because the product may not be sterile.

    Product
    iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Tear Film Replenishment Mild Sterile, 0.5 FL OZ (15 mL), Manufactured by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-142-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0420-2020·2019-11-27

    Altaire Ciprofloxacin Ophthalmic Solution Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling Ciprofloxacin HCL Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    CIPROFLOXACIN HCL OPHTHALMIC — CIPROFLOXACIN HCL OPHTHALMIC (CIPROFLOXACIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0477-2020·2019-11-27

    CVS Health Multi-Action Relief Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Multi-Action Relief Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the pharmacy.

    Product
    CVS Health Multi-Action Relief Drops, Item#: 694954, 15 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0426-2020·2019-11-27

    Altaire Goniotaire Ophthalmic Solution Recalled for Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling Goniotaire ophthalmic solution due to a lack of assurance of sterility. The recall affects 202,266 units distributed nationwide.

    Product
    GONIOTAIRE — GONIOTAIRE (HYPROMELLOSE 2906 (4000 MPA.S))
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0406-2020·2019-11-27

    CVS Health Preservative Free Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the pharmacy.

    Product
    CVS Health Preservative Free Lubricant Eye Drops Fast Acting, Item#: 258625 Product Size: 0.6 mL x 60 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2020·2019-11-27

    Altaire Recalls Perrigo Bacitracin Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Perrigo Bacitracin Ophthalmic Ointment because the product lacks assurance of sterility. The recall covers 651,528 units distributed nationwide.

    Product
    Perrigo Bacitracin Ophthalmic Ointment, Net Wt. 3.5 g (1/8 oz), Rx only, Manufactured For: Perrigo Minneapolis, MN 55427, NDC 0574-4022-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0467-2020·2019-11-27

    Altaire Recalls Natural Ophthalmics Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Natural Ophthalmics Allergy Desensitization Eye Drops because the company cannot ensure the product is sterile.

    Product
    Natural Ophthalmics Allergy Desensitization Eye Drops, 15 mL, NDC 68770-120-15
    Category
    Drug
    Distribution
    Distributed nationwide