The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

16176–16200 of 53092

  • HighFDA (Food)·F-1574-2022·2022-08-31

    Enjoy Life Soft Baked Cookies Recalled for Potential Hard Plastic Contamination

    Enjoy Life Natural Brands is recalling Enjoy Life Soft Baked Cookies (36 oz Amazon Variety Pack) nationwide due to potential hard plastic contamination. Approximately 89,736 cases are affected.

    Product
    Enjoy Life Soft Baked Cookies - 36 oz. Amazon Variety Pack - (2SND,1CC,1OAT,1SBCC,1MSTR; 6oz. each) UPC 819597014518
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1450-2022·2022-08-31

    Allergy Medications Recalled Due to Improper Storage Temperature Conditions

    Family Dollar Stores is recalling multiple allergy and sinus medications because they were held outside appropriate storage temperature conditions, which may affect their safety and efficacy.

    Product
    QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU 916003 QP ALLERGY MULTI SYMPTOM CAPLET 24CT SKU 916918 BENADRYL D CHILD ALLERGY SINUS GRAPE 4FO SKU 901738 GOOD SENSE CHILD ALLERGY CHERRY 4 FL OZ SKU 916917 BENADRYL ALLERGY…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2022·2022-08-31

    McKesson blood coagulation test kits recalled for temperature storage damage

    McKesson recalls Coag-Sense blood coagulation test kits nationwide due to facility temperature excursions that may have affected test effectiveness.

    Product
    a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1443-2022·2022-08-31

    Good Sense Lice Shampoo Recalled for Improper Storage Conditions

    Family Dollar Stores recalls Good Sense Lice Shampoo 6 FL OZ distributed April-June 2022 nationwide due to CGMP deviations from improper storage temperature conditions. Products may have compromised safety or efficacy.

    Product
    GOOD SENSE LICE SHAMPOO 6FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2022·2022-08-31

    LeadCare II Blood Lead Test Kit Recalled Due to Temperature Storage Issues

    81 kits of LeadCare II blood lead test devices were recalled because temperature exposure during storage may have impacted product effectiveness. The affected lots were received between June and September 2021.

    Product
    MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests Model Number: 70-6762
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1390-2022·2022-08-31

    Rubbing Alcohol Recalled for Improper Storage Temperature Conditions

    Family Dollar Stores recalled Ready In Case 50% Wintergreen Rubbing Alcohol (16 fl oz) distributed April 30–June 10, 2022 due to improper storage temperature conditions.

    Product
    READY IN CASE RUBBING ALCHL 50 PCT WNTRGRN 16 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1567-2022·2022-08-31

    Enjoy Life Chewy Bars recalled for hard plastic pieces

    Enjoy Life Natural Brands is recalling Chewy Bars Sunseed Crunch due to potential hard plastic fragments in the product. Affected products were distributed nationwide in the US and Canada.

    Product
    Enjoy Life Chewy Bars Sunseed Crunch, 5.75 oz UPC 853522000627
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2022·2022-08-31

    McKesson GYNECATH H/S Catheter Recalled Due to Temperature Excursions Prior to Delivery

    McKesson recalls gynecological catheters that may have been exposed to temperatures higher than intended during storage, potentially affecting product effectiveness. Affected units were received between June and September 2021.

    Product
    Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1429-2022·2022-08-31

    MIRALAX 8.3 OZ Recalled Due to Improper Storage Temperature Conditions

    Family Dollar Stores is recalling MIRALAX 8.3 OZ (SKU 902219) distributed nationwide from April 30 to June 10, 2022. The product was held outside appropriate storage temperatures, violating manufacturing standards.

    Product
    MIRALAX 8.3 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2022·2022-08-31

    Baxter DISCPAC Syringe Tip Caps recalled due to sterile barrier failure

    Baxter Healthcare is recalling DISCPAC Syringe Tip Caps because packaging may not maintain a sterile barrier. Affected units were distributed worldwide including the US, Australia, Finland, Germany, Spain, and the UK.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2022·2022-08-31

    Ultrasound Probe Disinfectant Recalled: Temperature Exposure May Affect Effectiveness

    Nanosonics Sonex-HL ultrasound probe disinfectant is recalled due to temperature excursions during storage that may have affected product effectiveness.

    Product
    NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1384-2022·2022-08-31

    Family Dollar Hydrocortisone and Cortizone Creams Recalled for Storage Deviation

    Family Dollar Stores is recalling hydrocortisone cream (1 oz, SKU 910321) and Cortizone 10 Creme (0.5 oz, SKU 910167) distributed April 30 through June 10, 2022, due to improper storage temperature conditions.

    Product
    FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1408-2022·2022-08-31

    Witch hazel product recalled for improper storage temperature conditions

    Witch hazel product distributed to Family Dollar Stores from April through June 2022 was stored at improper temperatures. The FDA issued a Class II recall due to manufacturing and quality control (CGMP) deviations.

    Product
    TN DICKINSON WITCH HAZEL 16 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1573-2022·2022-08-31

    Enjoy Life Brownie Bites recalled for potential hard plastic pieces

    Enjoy Life Natural Brands is recalling Brownie Bites - Salted Caramel (4.76 oz) due to potential hard plastic pieces. Approximately 89,736 cases were distributed nationwide in the US and Canada.

    Product
    Enjoy Life Brownie Bites Salted Caamel, 4.76 oz UPC 819597013313
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1362-2022·2022-08-31

    Divalproex Sodium Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Amneal Pharmaceuticals is recalling 4,309 bottles of Divalproex Sodium Extended-Release Tablets (250 mg) due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting medication effectiveness.

    Product
    DIVALPROEX SODIUM — DIVALPROEX SODIUM (DIVALPROEX SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1626-2022·2022-08-31

    LASIK Irrigation Cannula Recalled for Potential Temperature Exposure Damage

    Beaver-Visitec medical irrigation cannulas used in LASIK eye surgery are being recalled due to storage temperature excursions. Units distributed from June through September 2021 may have reduced effectiveness.

    Product
    BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1388-2022·2022-08-31

    Arthritis Pain Reliefs Recalled for Improper Storage Temperature Conditions

    Family Dollar Stores is recalling BC Arthritis Pain Fast Pain Relief and Good Sense Arthritis Caplet due to improper storage conditions. Products were distributed nationwide from April 30 through June 10, 2022.

    Product
    BC ARTHRITIS PAIN FAST PAIN RELIEF 24CT SKU 999839 GOOD SENSE ARTHRITIS CAPLET 24 CT SKU 914771 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1570-2022·2022-08-31

    Enjoy Life Oat Breakfast Ovals Recalled for Hard Plastic Contamination

    Enjoy Life Natural Brands is recalling Enjoy Life Soft Baked Fruit & Oat Breakfast Ovals due to potential hard plastic pieces in the product. Consumers should not consume affected items.

    Product
    Enjoy Life Soft Baked Fruit & Oat Breakfast Ovals Chocolate Chip Banana, 8.8 oz (250g) UPC 819597012576 and 819597012705
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1464-2022·2022-08-31

    Hand sanitizer recalled for use of expired active ingredient

    Corsair Personal Care 99X Instant Foam Hand Sanitizer is being recalled due to a manufacturing violation: it was made using expired benzalkonium chloride. Consumers should stop using the affected product.

    Product
    Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottles, Southern Products & Services, Inc. 2515 Jake Drive Ste B, Cumming, GA 30028
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-1432-2022·2022-08-31

    Facial Moisturizer Recalled for Improper Storage Temperature Conditions

    Family Dollar Stores is recalling AMBI Nursing Daily Facial Moisturizer 1.7 oz distributed nationwide from April 30 through June 10, 2022, because the product was held outside appropriate storage temperature conditions.

    Product
    AMBI NRSHNG DAILY FACIAL MSTURZER 1.7 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1454-2022·2022-08-31

    Multiple Cold and Flu Medications Recalled Due to Improper Storage Conditions

    Family Dollar Stores is recalling multiple cold and flu medications distributed April 30–June 10, 2022, because products were held outside appropriate storage temperature conditions.

    Product
    DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS 8 CT SKU 900523 ALKA SELTZER PLUS DAY NIGHT LGEL 20 CT SKU 902012 GS COLD FLU RELIEF NGHTTIME CHRY12FL OZ SKU 917523 RIC COLD FLU DAY TIME LIQUID CAP 16 CT SKU 903037 ASP SEVERE COLD COUGH…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2022·2022-08-31

    GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport

    GE Centricity and Universal Viewer software may produce inaccurate distance and area measurements in the Global Stack viewport. The FDA issued a Class II recall affecting 1,690 devices.

    Product
    (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1565-2022·2022-08-31

    Dental Implant Recall: Nobel Biocare Device Burr Aspiration Risk

    Nobel Biocare is recalling 347 N1 TiUltra TCC dental implants due to a burr that may pose an aspiration risk during surgical implantation. No injuries have been reported.

    Product
    Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1579-2022·2022-08-31

    Capriole Goat Cheese recalled for undeclared food dyes

    Capriole Fresh Goat Cheese products containing undeclared Blue #1 and Yellow #5 dyes are being recalled. Affected products were distributed in Kentucky, Illinois, and Indiana.

    Product
    Capriole Goat Cheese, Fresh Goat Cheese, Wasabi 5 pound and 8oz logs
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1585-2022·2022-08-31

    Medical Device Etching Solution Recalled for Potential Temperature-Related Effectiveness Loss

    ABX Pentra Etching CP solution is recalled due to temperature excursions from June-August 2021 that may have affected product effectiveness. Affected lots were distributed June 1 - September 30, 2021.

    Product
    HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769
    Category
    Medical Device
    Distribution
    Distributed nationwide