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.

10551–10575 of 29158

  • SevereNHTSA·19E081000·2019-12-02

    IMT Standen Recalls Leaf Spring Assemblies for Trailer Suspension Defects

    IMT Standen is recalling certain leaf spring assemblies for trailers because they may crack and break, posing a road hazard and increasing crash risk.

    Product
    SUSPENSION:REAR:SPRINGS:LEAF SPRING ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V856000·2019-12-02

    Subaru Recalls 2019 Models for Engine Valve Separation Risk

    Subaru is recalling 51,613 2019 Crosstrek, Forester, and Ascent vehicles because a PCV valve can separate, causing loss of power and increasing crash risk.

    Product
    SUBARU — SUBARU CROSSTREK, ASCENT, FORESTER
    Category
    Vehicle
    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-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-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-0441-2020·2019-11-27

    Altaire Recalls Tetcaine Ophthalmic Solution Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Tetcaine ophthalmic solution because the product may not be sterile. Patients should stop using the medication and consult a healthcare provider.

    Product
    Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution USP, 0. 5 fl oz (15 mL), Rx only, Manufactured for OCuSOFT, Inc. Rosenberg, TX 77471 USA, NDC 54799-502-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0155-2020·2019-11-27

    Talley Farms Cilantro Recalled Due to Cyclospora Contamination

    Talley Farms is recalling cilantro after FDA sampling detected Cyclospora. Consumers in AZ, CA, ID, and TX should discard the product.

    Product
    Arroyo Grande California Cilantro; Talley Farms; Product of USA - 30 or 60 Count Individual bunches tied with Talley Farms Arroyo Grande twist tie.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0318-2020·2019-11-27

    Russ Davis Wholesale Recalls Broccoli Slaw Kits for Listeria Risk

    Russ Davis Wholesale, Inc. is recalling 50 units of 3.25 lb Broccoli Slaw Kits due to potential Listeria monocytogenes contamination. The products were distributed to foodservice establishments and retailers in 11 states.

    Product
    Broccoli Slaw Kit, 3.25 lbs, packaged in a plastic bag and case labeled with an orange stick-on label.
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0422-2020·2019-11-27

    Altaire Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution due to a lack of assurance of sterility.

    Product
    FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE — FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE (FLUORESCEIN SODIUM AND PROPARACAINE HYDROCHLORIDE)
    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 (Food)·F-0290-2020·2019-11-27

    Mann Packing Recalls Sweet Kale Salad Blend Due to Listeria Risk

    Mann Packing Company is recalling Sweet Kale Salad Blend because it tested positive for Listeria monocytogenes following a notification from the CFIA.

    Product
    Mann's Nourish Bowls Basil Pesto 4 x 10.75 oz. UPC: 716519037030 4 x 10.75 oz. UPC; 716519037047 - Mann Canada
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0313-2020·2019-11-27

    Russ Davis Wholesale Recalls Broccoli Cheddar Pasta Salad Kits Due to Listeria Risk

    Russ Davis Wholesale, Inc. is recalling 1654 units of Broccoli Cheddar Pasta Salad Kit V because the product may be contaminated with Listeria monocytogenes.

    Product
    Broccoli Cheddar Pasta Salad Kit V, Large white generic label with Small White label, packaged in a plastic bag. Packaged for foodservice for deli
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0450-2020·2019-11-27

    OCuSOFT Tears Again Lubricant Eye Drops Recalled for Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Tears Again Lubricant Eye Drops due to a lack of assurance of sterility. The recall covers 81,217 units distributed nationwide.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0310-2020·2019-11-27

    Russ Davis Wholesale Recalls Veggie Trays for Listeria Risk

    Russ Davis Wholesale is recalling specific veggie trays and bowls because they may be contaminated with Listeria monocytogenes.

    Product
    Veggie Tray with Radishes - 3 lbs, in plastic container; Fresh Veggie Value Bowl - 2.5 lbs in plastic bowl. Brands: Crazy Fresh, Quick&Easy, or Plain Label. Ingredients: Broccoli, Cauliflower, Carrot, Celery, Radish
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0266-2020·2019-11-27

    Mann Packing Recalls Sweet Kale Salad Blend for Listeria

    Mann Packing Company is recalling Sweet Kale Salad Blend due to a positive test for Listeria monocytogenes.

    Product
    Signature Farms California Stir Fry 6 x 12 oz. UPC: 21130983414 Marketside 6 x 12 oz. UPC: 681131457460 UPC: 716519013065 9 x 12 oz : 6 x 12 oz. Same UPC. Two films: one for Canada and one for US. Two casepacks for US. Canada: Mann's 4 x 2 lbs. UPC: 71651902018
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0311-2020·2019-11-27

    Russ Davis Wholesale Recalls Plain Riced Broccoli for Listeria Risk

    Russ Davis Wholesale is recalling 980 units of Plain Riced Broccoli because they may be contaminated with Listeria monocytogenes. The products were sold in 11 states.

    Product
    Plain Riced Broccoli - 10 oz in a plastic container. Brands: Crazy Fresh, Quick&Easy, or Plain Label
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0306-2020·2019-11-27

    Russ Davis Wholesale Recalls Salad Mix Due to Listeria Risk

    Russ Davis Wholesale is recalling 13 oz salad mixes because they may be contaminated with Listeria monocytogenes. The products were distributed to retailers and foodservice establishments in 11 states.

    Product
    Tomato, Carrot, Broccoli & Snap Pea- 13 oz in clear plastic container. Brands: Crazy Fresh, Quick&Easy, or Plain Label
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0284-2020·2019-11-27

    Mann's Organic Veggie Hummus Recalled for Listeria Contamination

    Mann Packing Company is recalling Organic Veggie Hummus Snack Trays due to a positive test for Listeria monocytogenes.

    Product
    Mann's Snacking Favorites Organic Veggie Hummus Snack Tray 4 x 16.5 oz. UPC: 716519020582
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0451-2020·2019-11-27

    Altaire Recalls OCuSOFT Eye Drops Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling OCuSOFT Tears Again Sterile Lubricant Eye Drops because the company cannot guarantee the product's sterility.

    Product
    OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manufactured for OCuSOFT Inc., Rosenberg, TX 77471 USA, NDC 54799-904-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0366-2020·2019-11-27

    Altaire Recalls Equate Eye Gel Due to Sterility Concerns

    Altaire Pharmaceuticals is recalling Equate Comfort Gel Lubricant Eye Gel because the product lacks assurance of sterility.

    Product
    Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-197-49
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0396-2020·2019-11-27

    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 return it to the point of purchase.

    Product
    CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, Sterile, 0.5 fl. oz. (15 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
    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 (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