The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

16401–16425 of 29206

  • SevereFDA (Drugs)·D-0576-2017·2017-03-22

    Synergy Rx Recalls TRI-BLEACHING CREAM HQ Due to Sterility Concerns

    Synergy Rx is recalling TRI-BLEACHING CREAM HQ because the product lacks assurance of sterility and has CGMP deviations.

    Product
    TRI-BLEACHING CREAM HQ (retinoic Acid 0.05%, Hydroquinone 6%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1616-2017·2017-03-22

    Jerk Curry Powder Recalled for Lead Contamination

    Oriental Packing Co. is recalling specific lots of jerk curry powder because product samples and ingredients tested positive for lead.

    Product
    Hot/Spicy Jerk Curry Powder. Packaged under the names: Blue Mountain Country Hot Jamaican Jerk Curry Seasoning & Ocho Rios Spicy Jerk Curry Seasoning. Sold as 2 oz, 4 oz, 6 oz, 8 oz, 22 oz, and 5 lb.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0563-2017·2017-03-22

    Synergy Rx Recalls MALEK'S MAGIC Due to Sterility Assurance Issues

    Synergy Rx is recalling MALEK'S MAGIC prescription cream because it lacks assurance of sterility and has CGMP deviations.

    Product
    MALEK'S MAGIC (retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, hydrocortisone 1%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0541-2017·2017-03-22

    Synergy Rx Recalls Retinoic Acid Products Due to Sterility Concerns

    Synergy Rx is recalling various retinoic acid products due to a lack of assurance of sterility and CGMP deviations.

    Product
    RETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ACID 0.025%/CLINDAMYCIN 1.2% GEL, RETINOIC ACID 0.025%/ HYALURONIC ACID CREAM, RETINOIC ACID 0.05%/HYALURONIC ACID CREAM, RETINOIC ACID 0.1% IN CERAVE CREAM, RETINOIC ACID POWDER 1 GRAM, RETINOIC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0579-2017·2017-03-22

    Synergy Rx Recalls Tri-Bleaching Cream Due to Sterility Assurance Concerns

    Synergy Rx is recalling Tri-Bleaching Cream because the product lacks assurance of sterility and has CGMP deviations.

    Product
    TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 8%, Fluocinolone 0.01%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1613-2017·2017-03-22

    J M Exotic Foods Recalls Ground Turmeric Due to Elevated Lead Levels

    J M Exotic Foods Inc is recalling specific lots of ground turmeric because a supplier sample tested with elevated lead levels. The product was distributed in Georgia and Alabama.

    Product
    Ground Turmeric packaged as follows: a) FOOD LOCKER(R) , 16 oz, PHENIX FOOD SERVICE, PHENIX CITY, AL 36867 b) Ground Turmeric, Net Wt. 4 oz.,
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0525-2017·2017-03-22

    Synergy Rx Recalls Ketoconazole and Hydrocortisone Cream Due to Sterility Concerns

    Synergy Rx is recalling all lots of Ketoconazole 2%/Hydrocortisone 1.5% Cream because the product lacks assurance of sterility and has CGMP deviations.

    Product
    KETOCONAZOLE 2%/HYDROCORTISONE 1.5% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0601-2017·2017-03-22

    Synergy Rx Recalls Intimate Bleaching Cream Due to Sterility Assurance Issues

    Synergy Rx is recalling Intimate Bleaching Cream because the product lacks assurance of sterility and has CGMP deviations.

    Product
    INTIMATE BLEACHING CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0534-2017·2017-03-22

    Synergy Rx Recalls Topical Acne Medications Due to Sterility Concerns

    Synergy Rx is recalling specific clindamycin and tretinoin products due to a lack of assurance of sterility and CGMP deviations.

    Product
    CLINDAMYCIN 1%, AZELAIC ACID 10% CREAM, CLINDAMYCIN 1.2%/ TRETINOIN 0.05% GEL, CLINDAMYCIN 1.2%/ TRETINOIN 0.1% GEL CLINDAMYCIN 2.5%, BENZOYL PEROXIDE 5%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0562-2017·2017-03-22

    Synergy Rx Recalls LP Cream Due to Sterility Assurance Issues

    Synergy Rx is recalling LP Cream (Lidocaine 15%/Prilocaine 5%) because the product lacks assurance of sterility and has CGMP deviations.

    Product
    LP CREAM (Lidocaine 15%/Prilocaine 5%), Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1595-2017·2017-03-22

    Bee International Recalls Plastic Heart Tubes with Chocolate Lentils

    Bee International is recalling Plastic Heart Tubes with Chocolate Lentils because they may contain undeclared milk protein.

    Product
    Plastic Heart Tubes with Chocolate Lentils, Net Wt. 1.7oz (48g), UPC 0-73563-00805-9, 24 count tubes per case
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0549-2017·2017-03-22

    Synergy Rx Recalls Lactic Acid Solution Due to Sterility Concerns

    Synergy Rx is recalling Lactic Acid Solution in all strengths due to a lack of assurance of sterility and CGMP deviations.

    Product
    LACTIC ACID SOLUTION in all strengths including 20%, 30%, and 60%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0545-2017·2017-03-22

    Synergy Rx Recalls Urea 40% Cream Due to Sterility Concerns

    Synergy Rx is recalling Urea 40% Cream because it may not be sterile and has CGMP deviations.

    Product
    UREA 40% Cream, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V191000·2017-03-21

    Isuzu Recalls NPR, NQR, and NRR Trucks for Loose Wheel Bolts

    Isuzu is recalling 2011-2017 NPR, NQR, and NRR trucks because left rear wheel bearing hub locking bolts may be loose, increasing crash risk.

    Product
    ISUZU — ISUZU NRR, NQR, NPR, NPR XD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·028-2017·2017-03-21

    J & Y Dasung Recalls Frozen Pork Dumplings Produced Without Inspection

    J & Y Dasung, Inc. is recalling approximately 178,335 pounds of frozen pork dumplings produced without federal inspection. The products were shipped to retail locations in Southern California.

    Product
    J & Y Dasung, Inc. Recalls Pork Dumpling Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereCPSC·17112·2017-03-21

    Polaris Recalls Sportsman 850 and 1000 ATVs for Burn and Fire Hazards

    Polaris is recalling about 19,200 Sportsman 850 and 1000 ATVs because heat shields can melt and exhaust springs can stretch, posing burn and fire risks.

    Product
    Sportsman 850 and 1000 all-terrain vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V189000·2017-03-17

    BMW Recalls 2017 X5 Models Due to Air Bag Inflator Defect

    BMW is recalling 2017 X5 vehicles because the passenger air bag inflator may not vent properly, potentially causing metal fragments to strike occupants in a crash.

    Product
    BMW — BMW X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V187000·2017-03-17

    Entegra Motorhomes Recalled for Front Suspension Ball Joint Separation Risk

    Entegra is recalling specific Aspire, Cornerstone, and Anthem motorhomes because front suspension ball joints may loosen and separate, potentially causing a loss of steering control.

    Product
    ENTEGRA — ENTEGRA CORNERSTONE, ANTHEM, ASPIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·023-2017 EXP·2017-03-17

    King's Command Foods Recalls Beef Products Due To Foreign Matter

    King's Command Foods is recalling approximately 63,252 pounds of ground beef products, including meatballs and beef fritters, due to possible contamination with extraneous materials such as metal.

    Product
    King's Command Foods, LLC — King's Command Foods, LLC. Recalls Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·026-2017·2017-03-16

    Flagship Food Group Recalls Frozen Burritos Due to Plastic Contamination

    Flagship Food Group is recalling approximately 8,622 pounds of frozen breakfast burritos sold at Trader Joe's in Illinois and Pennsylvania due to possible hard clear plastic contamination.

    Product
    Flagship Food Group — Flagship Food Group Recalls Frozen Burrito Product Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1409-2017·2017-03-15

    FDA Recalls Premier Guard Drape Due to Sterility Compromise

    The FDA is recalling Premier Guard Drape, Sterile, because the sterile barrier was breached, compromising sterility. The product is used with RF Surgical Gauze detection systems.

    Product
    Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1428-2017·2017-03-15

    Villa Sistemi Medicali Recalls Apollo X-Ray Systems Due to Footrest Detachment

    Villa Sistemi Medicali is recalling 65 Apollo multi-function x-ray systems because the footrest detached from the table, causing a patient to fall.

    Product
    Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide