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.

10601–10625 of 29158

  • SevereFDA (Drugs)·D-0407-2020·2019-11-27

    CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Issues

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

    Product
    CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief, Sterile, 0.33 fl. oz. (10 mL), Item #968210, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    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-0364-2020·2019-11-27

    Equate Restore Tears Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Restore Tears Lubricant Eye Drops due to a lack of assurance of sterility. Consumers should stop using the product and return it to the place of purchase.

    Product
    Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-189-49
    Category
    Drug
    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 (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-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-0458-2020·2019-11-27

    Altaire Pharmaceuticals Recalls Accutome Rx Accu-WASH Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Accutome Rx Accu-WASH eye drops because the company cannot guarantee the product is sterile.

    Product
    Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for Accutome Inc 3222 Phoenixville Pike Malvern, PA 19355 USA Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 63448-411-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0259-2020·2019-11-27

    Signature Farms Veggie Deli Tray Recalled for Listeria

    Mann Packing Company is recalling Signature Farms Veggie Deli Trays due to a positive test for Listeria monocytogenes.

    Product
    Signature Farms Veggie Deli Tray 4 x 20.3 oz. UPC: 21130600489
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0410-2020·2019-11-27

    CVS Health Maximum Redness Relief Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Maximum Redness Relief Eye Drops due to a lack of assurance of sterility.

    Product
    CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 0.5 fl. oz., (15 mL), Item #994880, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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-0270-2020·2019-11-27

    Mann Packing Recalls Organic Veggie Trays Due to Listeria

    Mann Packing Company is recalling Organic Veggie Trays and Platters because a related salad blend tested positive for Listeria monocytogenes.

    Product
    Organic Veggie Tray: 4 x 18 oz. UPC: 79893108872 - OOR 4 x 16.25 oz. UPC: 716519020599 - Canada MSF Organic Veggie Tray - Large - no dip 4 x 36.5 oz. UPC: 79893981277 - O Organincs 4 x 16.5 oz. UPC: 716519014765 - Mann Snacking Favorites 4 x 16.5 oz. UPC: 71651902059
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0317-2020·2019-11-27

    Russ Davis Wholesale Recalls Vegetable Medley for Listeria Risk

    Russ Davis Wholesale is recalling Vegetable Medley products due to potential Listeria monocytogenes contamination. The affected items were distributed to foodservice establishments and retailers in 11 states.

    Product
    Vegetable Medley, 30/3.5 oz, packaged with a large generic white label on a plastic bag for foodservice use.
    Category
    Food
    Distribution
    11 states
  • 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-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-0489-2020·2019-11-27

    Clear Eyes Redness Relief Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling Clear Eyes Redness Relief 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
    Clear Eyes Redness Relief (Handy Pocket Pal), Product Size: 0.2 FL. Oz., UPC#: 6-78112-15418-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0403-2020·2019-11-27

    CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Concerns

    Altaire Pharmaceuticals is recalling CVS Health Fast Acting 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 Fast Acting Lubricant Eye Drops Dry Eye Therapy, Twin Pack Item#: 994881, 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-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-0447-2020·2019-11-27

    OCuSOFT Eye Wash Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling OCuSOFT Eye Wash due to a lack of assurance of sterility. Consumers should stop using the product and contact the manufacturer.

    Product
    OCuSOFT Eye Wash Sterile Isotonic Buffered Solution, 1 FL OZ (30 mL), Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-565-01
    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 (Food)·F-0277-2020·2019-11-27

    Mann's Cauliflower Sides Recalled for Listeria Contamination

    Mann Packing Company is recalling Mann's Veggies Sides Cauliflower due to a positive test for Listeria monocytogenes. The recall covers products with best-by dates from October 11, 2019, to November 16, 2019.

    Product
    Mann's Veggies Sides - Cauliflower 4 x 8.8 oz. oz., UPC: 716519012693
    Category
    Food
    Distribution
    0 states
  • 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-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-0384-2020·2019-11-27

    CVS Overnight Lubricating Eye Ointment Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling CVS Health Overnight Lubricating Eye Ointment due to a lack of assurance of sterility. The recall covers 284,232 units distributed nationwide.

    Product
    CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.5g), Item #881532, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0159-2020·2019-11-27

    Mical Seafood Recalls Tuna Poke Due to Scombroid Poisoning Complaints

    Mical Seafood is recalling specific lots of Tuna Poke because customer complaints reported cases of scombroid food poisoning potentially associated with the products.

    Product
    Tuna Poke CO AAA 2cm 10 lb case Tuna Poke COAAA 1.5cm 10 lb case
    Category
    Food
    Distribution
    0 states