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.

10651–10675 of 29158

  • SevereFDA (Drugs)·D-0425-2020·2019-11-27

    Altaire Sterile Eye Wash Recalled Due to Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling Altaire Sterile Eye Wash because the company cannot guarantee the product is sterile.

    Product
    Altaire Sterile Eye Wash, 118 mL (4 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-175-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0289-2020·2019-11-27

    Mann's Nourish Bowls Thai Noodle Recalled for Listeria Risk

    Mann Packing Company is recalling Mann's Nourish Bowls Thai Noodle due to a Listeria monocytogenes alert. The product was distributed in the US, Canada, and Japan.

    Product
    Mann's Nourish Bowls Thai Noodle 4 x 9.75 oz. UPC: 716519036989 US and Canada
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0446-2020·2019-11-27

    Altaire Recalls OCuSOFT Tetravisc Sterile Anesthetic Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Tetravisc Tetracaine HCl 0.5% sterile anesthetic because the company cannot guarantee the product is sterile.

    Product
    OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic, 5 mL, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 Made in USA, NDC 54799-505-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0385-2020·2019-11-27

    CVS Health Lubricant Eye Ointment Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Lubricant Eye Ointment due to a lack of assurance of sterility. The product is distributed nationwide.

    Product
    CVS Health Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5 g), Item #247781, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0445-2020·2019-11-27

    Altaire Recalls OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic

    Altaire Pharmaceuticals is recalling OCuSOFT Tetravisc Tetracaine HCl 0.5% sterile anesthetic single-dose vials due to a lack of assurance of sterility.

    Product
    OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 54799-505-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0452-2020·2019-11-27

    Altaire Recalls OCuSOFT Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT retaine NaCl Ophthalmic Ointment because the company cannot guarantee the product is sterile.

    Product
    OCuSOFT retaine NaCl Sodium Chloride Hypertonicity Opthalmic Ointment, Net. wt. 1/8 oz (3.5 g), Sterile, Distributed by OCuSOFT, Inc. Rosenberg, TX 77471 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0377-2020·2019-11-27

    CVS Health Dry Eye Relief Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Dry Eye Relief Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 101,712 units distributed nationwide.

    Product
    CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), Item #457802, 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-0389-2020·2019-11-27

    CVS Lubricant Eye Drops Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility.

    Product
    CVS Health Preservative Free Lubricant Eye Drops (Carboxymethyl-Cellulose Sodium 0.5%, Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #495301, NDC 50428 42216 8, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0472-2020·2019-11-27

    Altaire Recalls Nano Tears Lubricant Gel Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops because the product lacks assurance of sterility.

    Product
    Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, NDC 59390-144-51
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0394-2020·2019-11-27

    CVS Health Redness Relief Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Redness Relief Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product.

    Product
    CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0376-2020·2019-11-27

    CVS Health Dry Eye Relief Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Dry Eye Relief Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the point of purchase.

    Product
    CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0423-2020·2019-11-27

    Altaire Sterile Eye Wash Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling Altaire Sterile Eye Wash because the company cannot guarantee the product is sterile.

    Product
    Altaire Sterile Eye Wash, 15 mL (1/2 fl oz), Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931 NDC 59390-175-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0409-2020·2019-11-27

    CVS Health Lubricant Eye Drops Recalled for Sterility Concerns

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

    Product
    CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack, Item#: 495323, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0464-2020·2019-11-27

    Altaire Recalls Ortho-K Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Natural Ophthalmics Ortho-K Thin Eye Drops because the company cannot ensure the product is sterile.

    Product
    Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0374-2020·2019-11-27

    CVS Health Lubricant Eye Drops Recalled for Lack of Sterility Assurance

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

    Product
    CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, Sterile, 0.5 Fl. oz. (15 mL), Item #317916, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0354-2020·2019-11-27

    Altaire Recalls Neo-Polycin HC Ophthalmic Ointment Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling specific lots of Neo-Polycin HC ophthalmic ointment because the company cannot guarantee the product is sterile.

    Product
    Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic Ointment USP, Net Wt. 3.5 g (1/8 oz), Rx only, Mfd. For Perrigo Minneapolis, MN 55427, NDC 0574-4144-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0498-2020·2019-11-27

    Philips HeartStart XL+ Defibrillator Recall Due to Switch Failure

    Philips is recalling HeartStart XL+ Defibrillators because a faulty switch may cause the device to fail or deliver incorrect shock energy.

    Product
    HeartStart XL+ Defibrillator/Monitor, Model 861290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0371-2020·2019-11-27

    Altaire Recalls Equate Lubricant Gel Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Support Advanced Lubricant Gel Drops because the product lacks assurance of sterility. The recall affects 50,904 units distributed nationwide.

    Product
    Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M Item # 563031654, Package Size 7.5 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0444-2020·2019-11-27

    Altaire Recalls OCuSOFT Tetravisc Forte Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Tetravisc Forte eye drops because the company cannot guarantee the product is sterile.

    Product
    OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 mL, Mfd. For OCuSOFT, Inc. Rosenberg, TX 77471 Mfg. By: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 54799-504-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0440-2020·2019-11-27

    Altaire Recalls OCuSOFT Homatropine Hydrobromide Ophthalmic Solution Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, due to a lack of assurance of sterility. The recall covers 81,403 units distributed nationwide.

    Product
    OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manufactured for Ocusoft, Inc, Rosenberg, TX 77471, Mfd. by Altaire Pharmaceuticals, Inc, Aquebogue, NY 11931 NDC 54799-431-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0390-2020·2019-11-27

    CVS Lubricant Eye Drops Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility.

    Product
    CVS Health Preservative Free Lubricant Eye Drops (Carboxymethy-Cellulose Sodium 0.5%, Sensitive Solution, 70 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #457791, NDC 50428 41429 3, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0405-2020·2019-11-27

    CVS Health Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Fast Acting Lubricant Eye Drops due to a lack of assurance of sterility. The recall affects 58,704 units distributed nationwide.

    Product
    CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, Product Size: 0.6 mL x 24 ct, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0419-2020·2019-11-27

    Altaire Ciprofloxacin Ophthalmic Solution Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling Ciprofloxacin HCL Ophthalmic Solution due to a lack of assurance of sterility. The recall affects 3,060 units distributed nationwide.

    Product
    CIPROFLOXACIN HCL OPHTHALMIC — CIPROFLOXACIN HCL OPHTHALMIC (CIPROFLOXACIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide