The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

10251–10275 of 21617

  • ModerateFDA (Food)·F-1700-2018·2018-08-08

    Roctane Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling Roctane Ultra Endurance Energy Gels because testing confirmed the presence of cyclamates.

    Product
    Roctane Ultra Endurance Energy Gels: Blueberry Pomegranate, Roc Gel: ROC GEL 1 Pkt, Item # 123058, UPC: 769493105011; ROC GEL 15 Serve Pkt, Item # 124103. UPC: 769493100917; ROC GEL 24 Pkt Box, Item # 123065, UPC: 769493205018
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1716-2018·2018-08-08

    Advanced Food Concepts Recalls GU Energy Stroopwafels Due to Cyclamates

    Advanced Food Concepts is recalling GU Energy Stroopwafels because testing confirmed the presence of cyclamates, an ingredient not listed on the label.

    Product
    GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie; Caramel Coffee, Waffle; WAFFLE 1 Pkt, Item # 124203, UPC: 769493101631; WAFFLE 16 Pkt Box, Item # 124199, UPC:769493101594;
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1692-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels (Mint Chocolate) because testing confirmed the presence of cyclamates, a substance not permitted in food.

    Product
    GU Energy Gels: Mint Chocolate, Gel; GUGEL 1 Pkt; item # 124250, UPC:769493100108; GUGEL 24Pkt Box; item number 123943, UPC: 769493200136.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2591-2018·2018-08-08

    ELITech Recalls ENVOY 500 ISE Calibrator Kits Due to Calibration Failures

    ELITech Clinical Systems is recalling ENVOY 500 ISE Calibrator Kits because some vials cause calibration errors, delaying patient results.

    Product
    ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1673-2018·2018-08-08

    Apogee Foods Recalls Thunderbird Apple Pie Kid Bars for Temperature Issues

    Apogee Foods is recalling Thunderbird Apple Pie Kid Bars because the manufacturing process did not reach required temperatures. The product was distributed in Texas.

    Product
    Thunderbird Bars 1.15 oz Apple Pie Kid Bar (carton of 120)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1024-2018·2018-08-08

    West-Ward Recalls Doxycycline Hyclate Tablets for Dissolution Failures

    West-Ward Columbus Inc is recalling Doxycycline Hyclate 100 mg tablets because they failed to meet dissolution specifications.

    Product
    DOXYCYCLINE HYCLATE — DOXYCYCLINE HYCLATE (DOXYCYCLINE HYCLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2569-2018·2018-08-08

    Stryker FlowGate2 Balloon Guide Catheter Recalled for Diameter Defect

    Stryker Neurovascular is recalling FlowGate2 Balloon Guide Catheters because the balloon diameter may exceed specifications, potentially causing resistance during use.

    Product
    FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1689-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the presence of cyclamates, an ingredient not listed on the label.

    Product
    GU Energy Gels: Jet Blackberry, Gel; GUGEL 1 Pkt; item # 123022, UPC:769493100122 ; GUGEL 24Pkt Box; item number 123044, UPC: 769493200129.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1704-2018·2018-08-08

    Roctane Ultra Endurance Energy Gels Recalled for Potential Cyclamates

    Advanced Food Concepts is recalling Roctane Ultra Endurance Energy Gels because testing confirmed the presence of cyclamates.

    Product
    Roctane Ultra Endurance Energy Gels: Lemonade, Roc Gel: ROC GEL 1 Pkt, Item # 123064, UPC: 769493200440; ROC GEL 24 Pkt Box, Item # 123071, UPC: 769493200457.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2590-2018·2018-08-08

    Envoy Medical Recalls Esteem II Sound Processors with Expired Sterile Wipes

    Envoy Medical is recalling four Esteem II Sound Processors because the sterile wipes inside expired before the date labeled on the final pack.

    Product
    Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1719-2018·2018-08-08

    Advanced Food Concepts Recalls Waffle Products Due to Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Stroopwafels and Hoka Campfire Smores waffles because testing confirmed the presence of cyclamates.

    Product
    GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie;, Hoka Campfire Smores, Waffle; WAFFLE 1 Pkt, Item # 124513, UPC: 769493103222; WAFFLE 16 Pkt Box, Item # 124512, UPC:769493103215;
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1702-2018·2018-08-08

    Roctane Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling Roctane Ultra Endurance Energy Gels because testing confirmed the presence of cyclamates.

    Product
    Roctane Ultra Endurance Energy Gels: Cherry Lime, Roc Gel: ROC GEL 1 Pkt, Item # 123061, UPC:769493105059 ; ROC GEL 24 Pkt Box, Item # 123068, UPC: 769493205056.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1685-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the presence of cyclamates, an ingredient not declared on the label.

    Product
    GU Energy Gels: Cucumber Mint, Gel; GUGEL 1 Pkt; item # 124123, UPC ;769493101020; GUGEL 24Pkt Box; item number 124125 , UPC 769493101044.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1709-2018·2018-08-08

    Roctane Ultra Endurance Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling Roctane Ultra Endurance Energy Gels because testing confirmed the product may contain cyclamates.

    Product
    Roctane Ultra Endurance Energy Gels: Vanilla Orange Roc Gel: ROC GEL 1 Pkt, Item # 123059, UPC: 769493105028; ROC GEL 24 Pkt Box, Item # 123066, UPC:769493205025 .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1687-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels in French Toast flavor because testing confirmed the presence of cyclamates.

    Product
    GU Energy Gels: French Toast, Gel; GUGEL 1 Pkt; item # 124523, UPC:769493103239; GUGEL 24Pkt Box; item number 124528 , UPC: 769493103246 .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1713-2018·2018-08-08

    GU Energy Chews Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Chews because testing confirmed the presence of cyclamates, an ingredient not listed on the label.

    Product
    GU Energy Chews; Watermelon Chews; CHEWS 1 Pkt, Item # 124183, UPC: 769493101464 ; CHEWS 18 Pkt Box, Item # 124179, UPC:769493101426 .
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1688-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels because testing confirmed the product may contain cyclamates, an ingredient not listed on the label.

    Product
    GU Energy Gels: Gingerade, Gel; GUGEL 1 Pkt; item # 124297, UPC: 769493102409; GUGEL 24Pkt Box; item number 124296, UPC: 769493102393.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2600-2018·2018-08-08

    Encore Medical Recalls AltiVate Instrument Trays Due to Coating Issue

    Encore Medical is recalling 30 instrument trays used for AltiVate Small Shell Trials because a black coating may appear after cleaning that is not biocompatible.

    Product
    Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrum
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Food)·F-1722-2018·2018-08-08

    Advanced Food Concepts Recalls GU Energy Stroopwafels Due to Cyclamates

    Advanced Food Concepts is recalling GU Energy Stroopwafels because testing confirmed the presence of cyclamates, an unapproved food additive.

    Product
    GU Energy Stroopwafels; Dutch-Style syrup filled waffle cookie;, Salty's Caramel, Waffle; WAFFLE 1 Pkt, Item # 124205, UPC: 769493101655; WAFFLE 16 Pkt Box, Item # 124201, UPC: 769493101617.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1682-2018·2018-08-08

    GU Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling GU Energy Gels (Campfire Smores) because testing confirmed the presence of cyclamates.

    Product
    GU Energy Gels: Campfire Smores, Gel; GUGEL 1 Pkt; item # 124357, UPC 769493102614; GUGEL 24Pkt Box; item number 124358, UPC 769493102621
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1705-2018·2018-08-08

    Roctane Ultra Endurance Energy Gels Recalled for Potential Cyclamates

    Advanced Food Concepts is recalling Roctane Ultra Endurance Energy Gels because testing confirmed the presence of cyclamates.

    Product
    Roctane Ultra Endurance Energy Gels: Pineapple, Roc Gel: ROC GEL 1 Pkt, Item # 123060, UPC: 769493105035; ROC GEL 24 Pkt Box, Item # 123067, UPC: 769493205032.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1731-2018·2018-08-08

    PepsiCo Recalls Diet Pepsi 7.5 oz Cans Due to Undeclared Aspartame

    PepsiCo is recalling Diet Pepsi 7.5 oz 6-packs in five western states because the product contains undeclared aspartame.

    Product
    Diet Pepsi 7.5 oz cans, 6-pack. UPC on case label is 0 12000 16314 2. The product's case label is read in parts: "***diet pepsi***CARBONATED WATER, CARAMEL COLOR, PHOSPHORIC ACID, POTASSIUM BENZOATE (PRESERVES FRESHNESS), SUCRALOSE, ACESULFAME POTASSIUM, CAFFEINE, NATURAL FLA
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-1708-2018·2018-08-08

    Roctane Energy Gels Recalled for Potential Cyclamate Contamination

    Advanced Food Concepts is recalling Roctane Ultra Endurance Energy Gels because testing confirmed the presence of cyclamates.

    Product
    Roctane Ultra Endurance Energy Gels: Tutti Frutti Roc Gel: ROC GEL 1 Pkt, Item # 124315, UPC: 76949310247; ROC GEL 24 Pkt Box, Item # 124314, UPC: 769493102461.
    Category
    Food
    Distribution
    0 states
  • ModerateUSDA FSIS·065-2018·2018-08-03

    Van Oriental Foods Recalls Pork Egg Rolls Due to Plastic Contamination

    Van Oriental Foods Inc. is recalling pork egg rolls that may contain soft plastic. No illnesses have been reported.

    Product
    VAN Oriental Food, Inc. — Van Oriental Foods Inc. Recalls Pork Egg Rolls Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide