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.

10701–10725 of 29158

  • 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-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
  • SevereFDA (Food)·F-0255-2020·2019-11-27

    Mann Packing Recalls Cauliflower and Kale Products for Listeria

    Mann Packing Company is recalling specific lots of HEB and Mann's brand cauliflower and kale products due to a positive test for Listeria monocytogenes.

    Product
    HEB Brand Caulibits Chopped Cauliflower; 14 oz. UPC:41220093274 Mann's Brand: 2 lb. UPC: 10716519036788 2 lb. UPC: 10716519022989
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0388-2020·2019-11-27

    CVS Health Lubricant Eye Drops Recalled for Sterility Assurance Concerns

    Altaire Pharmaceuticals is recalling CVS Health Preservative Free Lubricant Eye Drops due to a lack of assurance of sterility. The recall covers 39,744 units distributed nationwide.

    Product
    CVS Health Preservative Free 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-0459-2020·2019-11-27

    Altaire Recalls Grandall Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Grandall Colirio Ojo De Aguila Eye Drops because the company cannot guarantee the product is sterile.

    Product
    Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By Grandall Distributing Co.Inc., Glendale, CA 91204-2707
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0490-2020·2019-11-27

    Clear Eyes Redness Relief Recalled Due to Sterility Assurance Issues

    Altaire Pharmaceuticals is recalling Clear Eyes Redness Relief eye drops because the company cannot ensure the product is sterile.

    Product
    Clear Eyes Redness Relief (Little Drug),Product Size: 0.2 FL. Oz., UPC#: 7-92554-70103-7
    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-0435-2020·2019-11-27

    Altaire Pharmaceuticals Recalls iSolutions Nano Tears XP Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling iSolutions Nano Tears XP eye drops because the company cannot guarantee the product is sterile.

    Product
    iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops Moderate Sterile, 1/3 FL OZ (10 mL), Mfd. By: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-143-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0287-2020·2019-11-27

    Mann's Nourish Bowls Sweet Potato Recalled for Listeria Risk

    Mann Packing Company is recalling Mann's Nourish Bowls Sweet Potato due to a positive test for Listeria monocytogenes.

    Product
    Mann's Nourish Bowls Sweet Potato 4 x 10.5 oz. UPC: 716519036866 - Mann Canada
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0429-2020·2019-11-27

    Altaire Pharmaceuticals Recalls iSolutions Nano Tears MXP Forte Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops because the company cannot ensure the product is sterile.

    Product
    iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-144-10
    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-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-0475-2020·2019-11-27

    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.

    Product
    Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0480-2020·2019-11-27

    Altaire Nano Tears XP Lubricant Gel Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling Nano Tears XP Clear Emollient Lubricant Gel Drops due to a lack of assurance of sterility.

    Product
    Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack, Product Size: 2 x 10 mL, Mfd. by: Altaire Pharmaceuticals, Inc., Aquebogue, NY 11931, NDC 59390-143-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0417-2020·2019-11-27

    Altaire Pharmaceuticals Recalls ActivEyes Altachlore Solution for Sterility Concerns

    Altaire Pharmaceuticals is recalling ActivEyes Altachlore Solution due to a lack of assurance of sterility. The recall covers 22,494 units distributed nationwide.

    Product
    ALTACHLORE SODIUM CHLORIDE HYPERTONICITY — ALTACHLORE SODIUM CHLORIDE HYPERTONICITY (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0413-2020·2019-11-27

    CVS Lubricant Eye Ointment Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling CVS Health Lubricant Eye Ointment Sensitive Formula due to a lack of assurance of sterility.

    Product
    CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
    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-0359-2020·2019-11-27

    Altaire Lubricant Eye Drops Recalled for Lack of Sterility Assurance

    Altaire Pharmaceuticals is recalling 35,896 units of Lubricant Eye Drops Moisturizing due to a lack of assurance of sterility.

    Product
    Lubricant Eye Drops Moisturizing (Carboxymethycellulose Sodium 0.5% Eye Lubricant), 0.5 oz. (15 mL), Distributed by: Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, Item #801483
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0431-2020·2019-11-27

    Altaire Pharmaceuticals Recalls iSolutions Nano Tears Eye Drops for Sterility Concerns

    Altaire Pharmaceuticals is recalling iSolutions Nano Tears MXP Forte eye drops due to a lack of assurance of sterility. The recall covers 48,973 units distributed nationwide.

    Product
    iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free, Product Size: 0.6 mL x 32 ct, Mfd. By: by Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-147-56
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·20031·2019-11-26

    Mark Feldstein Recalls Stacked Gourd Jack-O-Lanterns Due to Fire Hazard

    Mark Feldstein & Associates is recalling Stacked Gourd Jack-O-Lantern decorations because the internal wiring can overheat and ignite. Four reports of smoking or fire have been received.

    Product
    Stacked Gourd Jack-O-Lantern decorations
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V853000·2019-11-26

    BMW Recalls 1999-2001 3-Series Vehicles for Driver Air Bag Inflator Defect

    BMW is recalling 1999-2001 3-Series vehicles because a replacement driver air bag inflator may absorb moisture, potentially causing it to rupture or underinflate during a crash.

    Product
    BMW — BMW 328I, 323CI, 325CI, 328CI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V848000·2019-11-26

    Forest River Recalls 2020 XLR Boost Trailers Due to Axle Defect

    Forest River is recalling 2020 XLR Boost trailers because an undersized axle and tire combination may cause the trailer to be overloaded, increasing the risk of a crash.

    Product
    FOREST RIVER — FOREST RIVER XLR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19E080000·2019-11-26

    Takata Recalls Non-Azide Driver Air Bag Inflators for Moisture Absorption

    Takata is recalling specific non-azide driver air bag inflators used in 1995-2000 vehicles. The inflators may absorb moisture, risking rupture or underinflation during a crash.

    Product
    AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide